Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA - The Anti Tissue Transglutaminase-G (Anti-tTG-G) - AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Duns Number:784143778

Device Description: The Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA is a solid phase enzyme immunoassay The Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. Each device contains the following: microplate strips with breakaway microwells coated with recombinant human tTG and Gliadin-specific peptide antigen, six levels of calibrators (0, 3, 10, 30, 100, 300 U/mL); positive, negative and cut-off controls (human serum, diluted); wash buffer concentrate; sample buffer; goat anti-human immunoglobulin (IgG) horseradish peroxidase conjugate; 3,3’,5,5’ tetramethylbenzidine (TMB)/H2O2 substrate; and 1M hydrochloric acid stop solution.

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More Product Details

Catalog Number

35-TGGHU-E01

Brand Name

Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA

Version/Model Number

35-TGGHU-E01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K042644

Product Code Details

Product Code

MVM

Product Code Name

Autoantibodies, Endomysial(Tissue Transglutaminase)

Device Record Status

Public Device Record Key

b93053de-1d2c-4cde-8195-93726c8c0802

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN LABORATORY PRODUCTS COMPANY, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 42
2 A medical device with a moderate to high risk that requires special controls. 23