Panther Fusion® SARS-CoV-2 Assay

Submitted by heather.butler on Tue, 03/17/2020 - 11:02
US
Part # PRD-06391
Panther Fusion SARS-CoV-2 Assay
File: AW-21159-001_006_01.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 006
Letter of Authorization
File: EUA200014-S006 Hologic Panther EUA LOA reissue 03232022 FINAL.pdf
Country-Language: US - English
Valid Date:
From:
Part # EUA 200014 A001
Fact sheet for Healthcare Providers
File: EUA200014-S006 Hologic Panther HCP FS 03-23-2022.pdf
Country-Language: US - English
Valid Date:
From:
Part # EUA 200014 A001
Fact sheet for Patients
File: EUA200014-S006 Hologic Panther PATIENT FS 03-23-2022.pdf
Country-Language: US - English
Valid Date:
From:
Part # PRD-03546
Aptima Multitest Swab Specimen Collection Kit for SARS-CoV-2 Specimen Collection
File: AW-18109-001_005_01_2.pdf
Country-Language: English
Valid Date:
From:
Document Revision: 005
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-001_001_01_6.pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 001
Panther Fusion SARS-Cov-2 Assay Label
File: EUA200014 S006 Hologic Panther label 07232021 (unchanged).pdf
Country-Language: US - English
Valid Date:
From:
Document Revision: 002
Part # Document name Document Type Country-Language Document Revision Files Valid Date (YYYY-MM)
Worldwide
Part # PRD-06391
SARS-CoV-2 Assay (Panther Fusion™ System) - Canada
File: AW-21388-001_004_01.pdf
Country-Language: Canada - English
Valid Date:
From:
Document Revision: 004
Part # PRD-06391
SARS-CoV-2 Assay (Panther Fusion™ System) - Canada
File: AW-21388-2201_001_01.pdf
Country-Language: Canada - French
Valid Date:
From:
Document Revision: 001
Part # PRD-03546
Aptima Multitest Swab Specimen Collection Kit for SARS-CoV-2 Specimen Collection
File: AW-18109-001_005_01_3.pdf
Country-Language: OUS - English
Valid Date:
From:
Document Revision: 005
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-001_001_01_7.pdf
Country-Language: OUS - English
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2601_001_01_2.pdf
Country-Language: Czech Republic - Czech
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1901_001_01_2.pdf
Country-Language: Denmark - Danish
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2701_001_01_2.pdf
Country-Language: Estonia - Estonian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1701_001_01_2.pdf
Country-Language: Finland - Finnish
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2201_001_01_2.pdf
Country-Language: Canada - French Canadian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-901_001_01_2.pdf
Country-Language: France - French
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-801_001_01_2.pdf
Country-Language: Germany - German
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2801_001_01_2.pdf
Country-Language: Hungary - Hungarian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-701_001_01_2.pdf
Country-Language: Italy - Italian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-3001_001_01_2.pdf
Country-Language: Lithuania - Lithuanian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2901_001_01_2.pdf
Country-Language: Latvia - Latvian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1501_001_01_2.pdf
Country-Language: Netherlands - Dutch
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1801_001_01_2.pdf
Country-Language: Norway - Norgwegian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-3401_001_01_2.pdf
Country-Language: Poland - Polish
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-601_001_01_2.pdf
Country-Language: Portugal - Portuguese
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-3101_001_01_2.pdf
Country-Language: Romania - Romanian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-201_001_01_2.pdf
Country-Language: Russia - Russian
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-301_001_01_2.pdf
Country-Language: Spain - Spanish
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1601_001_01_2.pdf
Country-Language: Sweden - Swedish
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-3201_001_01_2.pdf
Country-Language: Slovakia - Slovak
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-1101_001_01_2.pdf
Country-Language: Greece - Greek
Valid Date:
From:
Document Revision: 001
Part # PRD-04339; PRD-06554
Specimen Lysis Tubes
File: AW-26255-2401_001_01_2.pdf
Country-Language: Latin America
Valid Date:
From:
Document Revision: 001
Part # Document name Document Type Country-Language Document Rev Files Valid Date (YYYY-MM)