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Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA

FDA UDI

Class II (US FDA UDI)

by American Laboratory Products Company

Identity

Trade Name
Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA FDA UDI
Generic Name
Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The Anti Tissue Transglutaminase-A (Anti-tTg-A) 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. FDA UDI
Model / Reference
35-TGAHU-E01 FDA UDI
Description
The Anti Tissue Transglutaminase-A (Anti-tTg-A) 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. FDA UDI

Identifiers

Catalog Number
35-TGAHU-E01 FDA UDI
Primary DI / UDI-DI
B24235TGAHUE010 FDA UDI
510(k) Number
K042644 FDA UDI
FDA Product Code
MVM FDA UDI
GMDN Term
Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K042644 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Laboratory Products Company

Sources (1)

  • FDA UDI 71af9082-f978-4b5f-9959-7d0031a4353e 37 fields · synced Jun 6, 2026