Bio-Rad - MULTISPOT HIV-1/HIV-2 Rapid Test Negative Control - Bio-RAD Laboratories, Inc.

Duns Number:844766394

Device Description: MULTISPOT HIV-1/HIV-2 Rapid Test Negative Control Serum (Human) 1.0 mL

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More Product Details

Catalog Number

26166

Brand Name

Bio-Rad

Version/Model Number

26166

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BP040046

Product Code Details

Product Code

MZF

Product Code Name

Test, Hiv Detection

Device Record Status

Public Device Record Key

5b2a60e1-35af-4af2-96ac-667a0538d4ae

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 98
3 A medical device with high risk that requires premarket approval 30