FDA.reportPublic FDA data

Aptima®

Primary DI
15420045506787
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, MAIN ASSAY, HCV QUANT, 100T, US IVD
Catalog number
ASY-08775
Device description
The Aptima® HCV Quant Dx assay is a real-time transcription-mediated amplification (TMA®) test used for both detection and quantitation of hepatitis C virus (HCV) RNA.
Published
2017-03-08
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
MZPASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233352000
P160023000
P160023001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233352000Aptima HCV Quant Dx AssayHologic, Inc.2024-07-24MZP
P160023000APTIMA HCV QUANT DX ASSAYHologic, Inc.2017-02-13MZP
P160023001APTIMA HCV QUANT DX ASSAYHologic, Inc.2017-02-13MZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045506787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550678715420045506787

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 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 human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

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
00884999050860Alinity mABBOTT MOLECULAR INC.MZP2023-08-18
00875197006391cobas® HCVRoche Molecular Systems, Inc.MZP2021-12-10
00884999047761Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999047822Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999047839Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999048652Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999037472RealTimeABBOTT MOLECULAR INC.MZP2017-12-15
04015630935390cobas 8800 SystemRoche Diagnostics GmbHMZP2017-04-20
04015630935406cobas 6800 SystemRoche Diagnostics GmbHMZP2017-04-20
15420045506794Aptima®Hologic, Inc.MZP2017-03-08
15420045506800Aptima®Hologic, Inc.MZP2017-03-08
00884999042681RealTimeABBOTT MOLECULAR INC.MZP2016-07-28
00875197004472cobas omni Wash Reagent WASH)Roche Diagnostics GmbHMZP2015-12-04
00875197004489cobas omni Specimen Diluent SPEC DIL)Roche Diagnostics GmbHMZP2015-12-04
00875197004496cobas omni Lysis Reagent LYS)Roche Diagnostics GmbHMZP2015-12-04
00875197004502cobas omni MGP Reagent MGP)Roche Diagnostics GmbHMZP2015-12-04
00875197004694cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 SystemRoche Diagnostics GmbHMZP2015-12-04
00875197004748cobas® HBV/HCV/HIV-1 Control KitRoche Diagnostics GmbHMZP2015-12-04
00875197005127cobas® NHP Negative Control KitRoche Diagnostics GmbHMZP2015-12-04
00884999000698RealTimeABBOTT MOLECULAR INC.MZP2014-12-01
00884999000704RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999000711RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999000728RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999037434RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999037656RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00630414472386VERSANT® HCV RNA 3.0 ASSAY bDNASiemens Healthcare Diagnostics Inc.MZP2014-09-24
00630414472393VERSANT® HCV RNA 3.0 ASSAY bDNASiemens Healthcare Diagnostics Inc.MZP2014-09-24
00875197004182COBAS® TaqMan® HCV Test For Use With the High Pure SystemRoche Molecular Systems, Inc.MZP2014-09-10
00875197001983COBAS® AmpliPrep/ COBAS® TaqMan® HCV TestRoche Molecular Systems, Inc.MZP2014-09-09
00875197003611COBAS® AmpliPrep / COBAS® TaqMan® HCV Test, v2.0Roche Molecular Systems, Inc.MZP2014-09-09