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Aptima SARS-CoV-2 Assay (Panther System)

Submitted by Anonymous (not verified) on Tue, 05/05/2020 - 15:36
US
Part # PRD-06419
Aptima® SARS-CoV-2 Assay (Panther® System)
File: AW-21492-001_010_01.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 10
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Part # 3-EUA2000734
FACT SHEET FOR HEALTHCARE PROVIDERS
File: EUA200734-S010 Hologic Aptima SARS2 HCP FS 03-23-2022.pdf
Country-Language: US - English
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Part # 4-EUA2000734
FACT SHEET FOR PATIENTS
File: EUA200734-S010 Hologic Aptima SARS2 PATIENT FS 03-23-2022.pdf
Country-Language: US - English
Valid Date:
From: Until:
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Part # EUA2000734
Letter of Authorization
File: EUA200734-S010 Hologic Aptima SARS2 EUA LOA reissue 03232022 FINAL.pdf
Country-Language: US - English
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Part # PRD-06997
Hologic® Direct Load Tube Collection Kit
File: AW-18114-001_003_01.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 003
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-23536-001_005_01.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 005
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-20232-001_004_01.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 004
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit
File: AW-18109-001_005_01.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 005
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-001_001_01_16.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 001
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Part # LBL-10198
Assay Kit Product Insert Card
File: AW-25564_001_05.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 001
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Part # LBL-10214
Controls Kit Product Insert Card
File: AW-25579_001_01.pdf
Country-Language: US - English
Valid Date:
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Document Revision: 001
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Part # LBL-10550
Direct Load Tube Product Insert Card
File: DLT-Product Information Card.pdf
Country-Language: US - English
Valid Date:
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Document Revision: 001
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Part # HPV004R01
Direct Load Capture Cap Collection Kit — CLASSIQSwabs Product Insert Card
File: DLCC-CLASSIQSwabs-Product Information Card.pdf
Valid Date:
From:
Document Revision: 001
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Part # HPV005R01
Direct Load Capture Cap Collection Kit — FLOQSwabs Product Insert Card
File: DLCC-FLOQSwabs-Product Information Card.pdf
Valid Date:
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Document Revision: 001
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Part # Document name Document Type Country-Language Document Revision Files Valid Date (YYYY-MM)
Worldwide
Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-001_004_01.pdf
Country-Language: EU – English
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
TRANSLATIONS INSERT, SARS-CoV-2
File: AW-24906_001_05_0.pdf
Country-Language: OUS - translations
Valid Date:
From:
Document Revision: 001
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-21491-001_002_01.pdf
Country-Language: OUS - English
Document Revision: 002
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-21677-001_006_01.pdf
Country-Language: Canada - English
Valid Date:
From:
Document Revision: 006
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-21677-2201_003_01.pdf
Country-Language: Canada - French
Valid Date:
From:
Document Revision: 003
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-21528-001_001_01.pdf
Country-Language: Australia - English
Valid Date:
From:
Document Revision: 001
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-1701_004_01.pdf
Country-Language: Finland - Finnish
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-1801_004_01.pdf
Country-Language: Norway – Norwegian
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-1901_005_01.pdf
Country-Language: Denmark – Danish
Valid Date:
From:
Document Revision: 005
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-2451_004_01.pdf
Country-Language: Spain – Spanish
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-21491-2401_002_01.pdf
Country-Language: Mexico - Spanish
Document Revision: 002
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-601_002_01.pdf
Country-Language: Portugal – Portuguese
Document Revision: 002
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-3001_005_01.pdf
Country-Language: Lithuania - Lithuanian
Valid Date:
From:
Document Revision: 005
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-701_004_01.pdf
Country-Language: Italy – Italian
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-801_004_01.pdf
Country-Language: Germany – German
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-901_005_01.pdf
Country-Language: France – French
Valid Date:
From:
Document Revision: 005
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-1501_004_01.pdf
Country-Language: Netherlands - Dutch
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-1601_004_01.pdf
Country-Language: Sweden - Swedish
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-2451_004_01_0.pdf
Country-Language: Latin America - Latin American Spanish
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-201_004_01.pdf
Country-Language: Russia - Russian
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-2901_004_01.pdf
Country-Language: Latvia - Latvian
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-2701_004_01.pdf
Country-Language: Estonia - Estonian
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-3101_004_01_0.pdf
Country-Language: Romania - Romanian
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-3201_004_01.pdf
Country-Language: Slovakia - Slovak
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-1101_004_01.pdf
Country-Language: Greece - Greek
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-3401_004_01_0.pdf
Country-Language: Poland - Polish
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-2801_004_01.pdf
Country-Language: Hungary - Hungarian
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-601_004_01.pdf
Country-Language: Portugal - Portuguese
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-22752-2601_004_01.pdf
Country-Language: Czech Republic - Czech
Valid Date:
From:
Document Revision: 004
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Part # PRD-06419
Aptima™ SARS-CoV-2 Assay (Panther™ System)
File: AW-27810-001_001_01.pdf
Country-Language: Singapore - English
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-001_003_01.pdf
Country-Language: OUS - English
Valid Date:
From:
Document Revision: 003
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-301_001_01_1.pdf
Country-Language: Spain - Spanish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-601_001_01_1.pdf
Country-Language: Portugal - Portuguese
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-701_001_01_1.pdf
Country-Language: Italy - Italian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-801_001_01_1.pdf
Country-Language: Germany - German
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-901_001_01_1.pdf
Country-Language: France - French
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-1501_001_01_1.pdf
Country-Language: Netherlands - Dutch
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-1601_001_01_1.pdf
Country-Language: Sweden - Swedish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-1701_001_01_0.pdf
Country-Language: Finland - Finnish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-1801_001_01_1.pdf
Country-Language: Norway - Norwegian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-1901_001_01_2.pdf
Country-Language: Denmark - Danish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-2701_001_01_2.pdf
Country-Language: Estonia - Estonian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-2601_001_01_2.pdf
Country-Language: Czech Republic
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-2801_001_01_1.pdf
Country-Language: Hungary - Hungarian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-2901_001_01_1.pdf
Country-Language: Latvia - Latvian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-3101_001_01_1.pdf
Country-Language: Romania - Romanian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-3201_001_01_1.pdf
Country-Language: Slovakia - Slovak
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-3401_001_01_1.pdf
Country-Language: Poland - Polish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-3001_001_01_0.pdf
Country-Language: Lithuania - Lithuanian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06951
Hologic® Direct Load Capture Cap Collection Kit — CLASSIQSwabs™
File: AW-26527-1101_001_01_1.pdf
Country-Language: Greece - Greek
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-001_001_01_0.pdf
Country-Language: UK-English
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-301_001_01.pdf
Country-Language: Spain - Spanish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-601_001_01.pdf
Country-Language: Portugal - Portuguese
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-701_001_01.pdf
Country-Language: Italy - Italian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-801_001_01.pdf
Country-Language: Germany - German
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-901_001_01.pdf
Country-Language: France - French
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-1501_001_01.pdf
Country-Language: Netherlands - Dutch
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-1601_001_01.pdf
Country-Language: Sweden - Swedish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-1701_001_01.pdf
Country-Language: Finland - Finnish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-1801_001_01.pdf
Country-Language: Norway - Norwegian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-1901_001_01.pdf
Country-Language: Denmark - Danish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-2601_001_01.pdf
Country-Language: Czech Republic - Czech
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-2701_001_01.pdf
Country-Language: Estonia - Estonian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-3101_001_01.pdf
Country-Language: Romania - Romanian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-2901_001_01.pdf
Country-Language: Latvia - Latvian
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-3201_001_01.pdf
Country-Language: Slovakia - Slovak
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-3401_001_01.pdf
Country-Language: Poland - Polish
Valid Date:
From:
Document Revision: 001
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Part # PRD-06952
Hologic® Direct Load Capture Cap Collection Kit — FLOQSwabs™
File: AW-26526-3001_001_01.pdf
Country-Language: Lithuania - Lithuanian
Valid Date:
From:
Document Revision: 001
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit for SARS-CoV-2 Specimen Collection
File: AW-18109-001_005_01.pdf
Country-Language: OUS – English
Valid Date:
From:
Document Revision: 005
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit voor afname van SARS-CoV-2-monsters
File: AW-26689-1501_001_01.pdf
Country-Language: Netherlands - Dutch
Valid Date:
From: Until:
Document Revision: 001
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit för insamling av provmaterial för SARS-CoV-2
File: AW-18109-1601_003_01.pdf
Country-Language: Sweden - Swedish
Valid Date:
From: Until:
Document Revision: 003
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit SARS-CoV-2-näytteenottoa varten
File: AW-18109-1701_003_01.pdf
Country-Language: Finland - Finnish
Valid Date:
From: Until:
Document Revision: 003
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit for SARS-CoV-2-prøvetaking
File: AW-18109-1801_003_01.pdf
Country-Language: Norway – Norwegian
Valid Date:
From: Until:
Document Revision: 003
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit til SARS-CoV-2-prøveindsamling
File: AW-18109-1901_003_01.pdf
Country-Language: Denmark – Danish
Valid Date:
From: Until:
Document Revision: 003
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit para recogida de muestras de SARS-CoV-2
File: AW-18109-301_004_01.pdf
Country-Language: Spain – Spanish
Valid Date:
From: Until:
Document Revision: 004
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit para colheita de espécimes de SARS-CoV-2
File: AW-26689-601_001_01.pdf
Country-Language: Portugal – Portuguese
Valid Date:
From:
Document Revision: 001
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit per la raccolta di campioni per SARS-CoV-2
File: AW-26689-701_001_01.pdf
Country-Language: Italy – Italian
Valid Date:
From:
Document Revision: 001
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit für die Entnahme von SARS-CoV-2-Proben
File: AW-26689-801_001_01.pdf
Country-Language: Germany – German
Valid Date:
From:
Document Revision: 001
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit pour le prélèvement de spécimens du SARS-CoV-2
File: AW-26689-901_001_01.pdf
Country-Language: France – French
Valid Date:
From:
Document Revision: 001
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit pour le prélèvement de spécimens du SARS-CoV-2
File: AW-18109-201_004_01.pdf
Country-Language: Russia - Russian
Valid Date:
From: Until:
Document Revision: 004
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Part # PRD-03546
Aptima® Multitest Swab Specimen Collection Kit pour le prélèvement de spécimens du SARS-CoV-2
File: AW-18109-2401_004_01.pdf
Country-Language: Latin America - Spanish
Valid Date:
From: Until:
Document Revision: 004
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-301_001_01_6.pdf
Country-Language: Spain - Spanish
Valid Date:
From:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-601_001_01_7.pdf
Valid Date:
From:
Document type: Portugal - Portuguese
Document Revision: 001
Download
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-701_001_01_5.pdf
Country-Language: Italy - Italian
Valid Date:
From:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-801_001_01_6.pdf
Country-Language: Germany - German
Valid Date:
From:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-901_001_01_6.pdf
Country-Language: France - French
Valid Date:
From:
Document Revision: 001
Download
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1501_001_01_5.pdf
Country-Language: Netherlands - Dutch
Valid Date:
From:
Document Revision: 001
Download
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1601_001_01_6.pdf
Country-Language: Sweden - Swedish
Valid Date:
From:
Document Revision: 001
Download
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1701_001_01_7.pdf
Country-Language: Finland - Finnish
Valid Date:
From:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1801_001_01_7.pdf
Country-Language: Norway - Norwegian
Valid Date:
From:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1901_001_01_8.pdf
Country-Language: Denmark - Danish
Valid Date:
From: Until:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2201_001_01_7.pdf
Country-Language: Canada - French
Valid Date:
From:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2401_001_01_5.pdf
Country-Language: Latin America - Spanish
Valid Date:
From:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2601_001_01_8.pdf
Country-Language: Czech Republic- Czech
Valid Date:
From:
Document Revision: 001
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Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2701_001_01_7.pdf
Country-Language: Estonia-Estonian
Valid Date:
From:
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