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OraQuick HCV Rapid Antibody Test

FDA UDI

Class II (US FDA UDI)

by OraSure Technologies, Inc.

Identity

Trade Name
OraQuick HCV Rapid Antibody Test FDA UDI
Generic Name
Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical FDA UDI
Model / Reference
3001-1521 FDA UDI

Identifiers

Primary DI / UDI-DI
00608337000535 FDA UDI
PMA Number
P080027 FDA UDI
FDA Product Code
MZO FDA UDI
GMDN Term
Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3169 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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 total antibody IVD, kit, rapid ICT, clinical

OraQuick HCV Rapid Antibody Test by OraSure Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical.

Cleared under the same submission

P080027 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OraSure Technologies, Inc.

Sources (1)

  • FDA UDI 29996d94-1b25-4445-92d6-68cdf28141f8 35 fields · synced Jun 9, 2026