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Aptima®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Aptima® FDA UDI
Generic Name
Hepatitis C virus nucleic acid IVD, calibrator FDA UDI
Device Name
Aptima® HCV Quant Dx Assay Calibrator. FDA UDI
Model / Reference
KIT, CALIBRATOR, HCV QUANT, US IVD FDA UDI
Description
Aptima® HCV Quant Dx Assay Calibrator. FDA UDI

Identifiers

Catalog Number
PRD-03707 FDA UDI
Primary DI / UDI-DI
15420045506800 FDA UDI
PMA Number
P160023 FDA UDI
FDA Product Code
MZP FDA UDI
GMDN Term
Hepatitis C virus nucleic acid IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3170 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: Hepatitis C virus 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 Hepatitis C virus nucleic acid IVD, calibrator.

Cleared under the same submission

P160023 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 e72a281c-8fed-4812-8518-1023df6f2773 37 fields · synced Jun 1, 2026