Catalog Number

-

Brand Name

OraQuick HCV Rapid Antibody Test

Version/Model Number

3001-1521

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027,P080027

Product Code

MZO

Product Code Name

Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus

Public Device Record Key

29996d94-1b25-4445-92d6-68cdf28141f8

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 05, 2014

Package DI Number

20608337000539

Quantity per Package

25

Contains DI Package

00608337000535

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-