FDA.reportPublic FDA data

Aptima®

Primary DI
15420045514560
Brand
Aptima®
Company
Hologic, Inc.
Model
CMV, TER, APTIMA, IVD
Catalog number
PRD-05077
Device description
Aptima® CMV Quant Assay Target Enhancer Reagent.
Published
2022-06-01
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
PABCytomegalovirus (cmv) dna quantitative assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PABCytomegalovirus (Cmv) Dna Quantitative AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243935000
P210029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243935000Aptima CMV Quant AssayHologic, Inc.2025-01-17PAB
P210029000Aptima CMV Quant AssayHologic, Inc.2022-05-09PAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045514560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551456015420045514560

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) nucleic acid IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
00884999051065Alinity mABBOTT MOLECULAR INC.PAB2024-02-22
15420045514553Aptima®Hologic, Inc.PAB2022-06-01
15420045514577Aptima®Hologic, Inc.PAB2022-06-01
15420045514584Aptima®Hologic, Inc.PAB2022-06-01
00884999049598Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049604Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049611Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049956Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00875197006421cobas® CMVRoche Molecular Systems, Inc.PAB2021-12-10
00875197006490cobas® CMV Control KitRoche Molecular Systems, Inc.PAB2021-12-10
04053228024538artus® CMV QS-RGQ MDx KitQIAGEN GmbHPAB2018-05-04
00875197004922cobas CMVRoche Molecular Systems, Inc.PAB2017-07-06
00875197004939cobas CMV Control KitRoche Molecular Systems, Inc.PAB2017-07-06
00884999045774RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999045781RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999045798RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999047297RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999046603RealTimeABBOTT MOLECULAR INC.PAB2017-04-17
04053228002086artus® CMV RGQ MDx KitQIAGEN GmbHPAB2017-01-04
00875197002584COBAS® AmpliPrep/ COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.PAB2014-09-10