OraQuick Advance Rapid HIV 1/2 Antibody Test - Orasure Technologies, Inc.

Duns Number:114152184

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More Product Details

Catalog Number

-

Brand Name

OraQuick Advance Rapid HIV 1/2 Antibody Test

Version/Model Number

3001-1197

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047,BP010047

Product Code Details

Product Code

MTL

Product Code Name

Monitor,Test,Hiv-1

Device Record Status

Public Device Record Key

d6678785-c442-4d19-bfc7-a95495627ef9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 05, 2014

Additional Identifiers

Package DI Number

20608337000010

Quantity per Package

25

Contains DI Package

00608337000016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"ORASURE TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 35
3 A medical device with high risk that requires premarket approval 2
U Unclassified 3