Catalog Number

-

Brand Name

OraQuick In Home HIV Test

Version/Model Number

1001-0340

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MZF

Product Code Name

Test, Hiv Detection

Public Device Record Key

5c176c94-2ea1-4168-bfe9-2767348f799c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 05, 2014

Package DI Number

10608337103400

Quantity per Package

6

Contains DI Package

00608337103403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton