FDA.reportPublic FDA data

Aptima®

Primary DI
15420045516991
Brand
Aptima®
Company
Hologic, Inc.
Model
BOX 1, REFRIG, SARS-COV-2 ASSAY, APTIMA 100T, IVD
Catalog number
ASY-17189
Device description
Aptima® SARS-CoV-2 Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Published
2025-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QQXRespiratory specimen nucleic acid SARS-CoV-2 test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243396000Aptima SARS-CoV-2 AssayHologic, Inc.2025-02-13QQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045516991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551699115420045516991

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
050579217
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20816101027136Simplexa COVID-19 Positive Control GEN II Pack DIASORIN MOLECULAR LLCQQX2025-09-17
15420045517004Aptima®Hologic, Inc.QQX2025-03-14
15420045517035Aptima®Hologic, Inc.QQX2025-03-14
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019422Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay KitLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
80190302019438Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019446Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR ControlLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
07332940008581GeneXpert®CEPHEIDQQX2024-01-22
00382904453619BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-12-09
00382904453732BD Respiratory Viral Panel for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-09-28
00875197006841cobas® SARS-CoV-2 Qualitative 192TRoche Molecular Systems, Inc.QQX2023-09-12
00875197006858cobas® SARS-CoV-2 Qualitative Control KitRoche Molecular Systems, Inc.QQX2023-09-12
00875197006933cobas® SARS-CoV-2 Qualitative 480TRoche Molecular Systems, Inc.QQX2023-09-12
20816101027020Simplexa COVID-19 DirectDIASORIN MOLECULAR LLCQQX2023-06-16
20816101027037Simplexa COVID-19 Positive Control PackDIASORIN MOLECULAR LLCQQX2023-06-16
00851458005228BioFire® COVID-19 Test 2BIOFIRE DEFENSE, LLCQQX2023-02-16
00851458005235BioFire® COVID-19 Test 2BIOFIRE DEFENSE, LLCQQX2023-02-16
06973342000530COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-02-02
06973342000158COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-01-30
10789594001002MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001088MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001095MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001101MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001354MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001361MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001378MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16