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OraQuick HCV Rapid Antibody Test Kit Controls

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1001-0278

by OraSure Technologies, Inc.

Identity

Trade Name
OraQuick® HCV Rapid Antibody Test Kit Controls EUDAMED
OraQuick HCV Rapid Antibody Test Kit Controls FDA UDI
Generic Name
Hepatitis C virus antibody/antigen IVD, control FDA UDI
Device Name
OraQuick HCV Rapid Antibody Test Kit Controls EUDAMED
Model / Reference
1001-0278 EUDAMED
1001-0182 FDA UDI

Identifiers

Primary DI / UDI-DI
00608337000528 EUDAMED
00608337000542 FDA UDI
Basic UDI-DI
B-00608337000528 EUDAMED
PMA Number
P080027 FDA UDI
FDA Product Code
MZO FDA UDI
EMDN Code
W0105090202 HCV ANTIBODY -RT & POC EUDAMED
GMDN Term
Hepatitis C virus antibody/antigen IVD, control FDA UDI

Classification

Device Class
Class IVD Annex II List A EUDAMED
Class II FDA UDI
Regulation Number
866.3169 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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 antibody/antigen IVD, control

OraQuick HCV Rapid Antibody Test Kit Controls by OraSure Technologies, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Hepatitis C virus antibody/antigen IVD, control.

Cleared under the same submission

P080027 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OraSure Technologies, Inc.

Sources (2)

  • FDA UDI b3c9ccd1-3e18-4c1f-be5c-239d90483314 35 fields · synced Jul 10, 2026
  • EUDAMED 947cb6b7-48e7-4bc8-9c6d-57010158836d 61 fields · synced Jul 10, 2026