AccessGUDID - DEVICE: QUANTA Lite® R h-tTG IgA ELISA (08426950544463)

GUDID

Device Identifier (DI) Information

Brand Name: QUANTA Lite® R h-tTG IgA ELISA
Version or Model: 704605
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08426950544463
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: 1. Instruction leaflet: Giving full assay details. 2.QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use. 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. R h-tTG IgA Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use. 7.R h-tTG IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 8.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 9. HRP R h-tTG IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. Ready to use. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use. 11.Stop Solution HRP: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040466	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 70af5c83-120f-4e5e-b0d8-949f79ca78a2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016