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Aptima®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Aptima® FDA UDI
Generic Name
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control FDA UDI
Device Name
Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA®) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. FDA UDI
Model / Reference
KIT, BOX 1, REFRIGERATED, ABV, 250T, IVD FDA UDI
Description
Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA®) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. FDA UDI

Identifiers

Catalog Number
ASY-16712 FDA UDI
Primary DI / UDI-DI
15420045517059 FDA UDI
510(k) Number
K243345 FDA UDI
FDA Product Code
PQA FDA UDI
PMN FDA UDI
NSU FDA UDI
GMDN Term
Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3975 FDA UDI
866.3920 FDA UDI
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control

Aptima® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control.

Cleared under the same submission

K243345 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI c03ffd9e-8dc7-4297-9d06-8e2ad4e9ee09 37 fields · synced May 30, 2026