AccessGUDID - DEVICE: Aptiva® Celiac Disease IgG Reagent (08430793040471)

GUDID

Device Identifier (DI) Information

Brand Name: Aptiva® Celiac Disease IgG Reagent
Version or Model: 724100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08430793040471
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: 1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives

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?
54813	Multiple Coeliac disease-associated antibody IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple antibodies associated with Coeliac disease in a clinical specimen, using a multiplex 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).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)
MST	Antibodies, Gliadin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200230	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: fc114443-0242-49f3-8666-abeb86f61eaf
Public Version Date: June 06, 2022
Public Version Number: 1
DI Record Publish Date: May 27, 2022