Bio-Rad - HSV Type 2 Specific IgG EIA Test Set - Bio-RAD Laboratories, Inc.

Duns Number:844766394

Device Description: HSV Type 2 Specific IgG EIA Test Set

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More Product Details

Catalog Number

12008531

Brand Name

Bio-Rad

Version/Model Number

12008531

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

K152353

Product Code Details

Product Code

MYF

Product Code Name

Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2

Device Record Status

Public Device Record Key

13c9e4f1-81a2-4185-a4ad-e22681195d63

Public Version Date

January 23, 2020

Public Version Number

2

DI Record Publish Date

May 28, 2019

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