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Aptima®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
APTIMA® FDA UDI
Generic Name
HIV1 nucleic acid IVD, calibrator FDA UDI
Device Name
Aptima® HIV-1 Quant Dx Assay Calibrator. FDA UDI
Model / Reference
KIT, CALIBRATORS, HIV QUANT, US IVD FDA UDI
Description
Aptima® HIV-1 Quant Dx Assay Calibrator. FDA UDI

Identifiers

Catalog Number
PRD-03566 FDA UDI
Primary DI / UDI-DI
15420045504226 FDA UDI
FDA Product Code
MZF FDA UDI
GMDN Term
HIV1 nucleic acid IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3956 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: HIV1 nucleic acid IVD, calibrator

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

Similar devices

Also classified as HIV1 nucleic acid IVD, calibrator.

Cleared under the same submission

BP150318 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 752878c5-a657-4d48-8bf9-a70a2e891d2f 37 fields · synced Jun 8, 2026