Autoimmune EIA - Autoimmune EIA Anti-Tissue Transglutaminase (tTG) - BIO-RAD LABORATORIES, INC.

Duns Number:884513334

Device Description: Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA

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More Product Details

Catalog Number

4252260

Brand Name

Autoimmune EIA

Version/Model Number

425-2260

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K042644

Product Code Details

Product Code

MVM

Product Code Name

Autoantibodies, endomysial(tissue transglutaminase)

Device Record Status

Public Device Record Key

4c50979a-7aef-4cf3-936e-8af58520833b

Public Version Date

July 29, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

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
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 428
U Unclassified 1