Autostat II Anti-Tissue Transglutaminase IgA - 96 well ELISA for the detection of Anti-Tissue - HYCOR BIOMEDICAL LLC

Duns Number:010558476

Device Description: 96 well ELISA for the detection of Anti-Tissue Transglutaminase IgA antibodies in human se 96 well ELISA for the detection of Anti-Tissue Transglutaminase IgA antibodies in human serum

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More Product Details

Catalog Number

-

Brand Name

Autostat II Anti-Tissue Transglutaminase IgA

Version/Model Number

FGA25

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

K033744

Product Code Details

Product Code

MVM

Product Code Name

Autoantibodies, Endomysial(Tissue Transglutaminase)

Device Record Status

Public Device Record Key

2acee00f-c25a-4064-88f0-935817b93001

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HYCOR BIOMEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 158
2 A medical device with a moderate to high risk that requires special controls. 148