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

Basic Information

• Brand Name: Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA
• Primary DI: B24235TGGHUE010
• Version / Model: 35-TGGHU-E01
• Catalog Number: 35-TGGHU-E01
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Labeler DUNS: 784143778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-18
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b93053de-1d2c-4cde-8195-93726c8c0802

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54812	Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen, using an enzyme immunoassay (EIA) method. These antibodies may include autoimmune antibodies directed at gliadin (anti-gliadin IgA or IgG), endomysium (anti-endomysial antibodies), immunoglobulin A (anti-IgA) and/or tissue transglutaminase antibodies (anti-tTG).	No	Active
55223	Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to tissue transglutaminase (anti-tTG) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B24235TGGHUE010	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K042644	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius