FDA.reportPublic FDA data

Aptima®

Primary DI
15420045514577
Brand
Aptima®
Company
Hologic, Inc.
Model
CMV, CALIBRATOR KIT, APTIMA, IVD
Catalog number
PRD-05075
Device description
Aptima® CMV Quant Assay Calibrators Kit.
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
15420045514577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551457715420045514577

GMDN Terms#

Term, Definition table
TermDefinition
Elbow/wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to encompass the elbow joint, the wrist joint, and the whole or part of the hand to support, correct, or improve function of the elbow, wrist, and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-35 Degrees Celsius-15 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
15420045514560Aptima®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