Aptiva® Celiac Disease IgA Reagent

Basic Information

• Brand Name: Aptiva® Celiac Disease IgA Reagent
• Primary DI: 08430793040532
• Version / Model: 724120
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-27
• Public Version: 1
• Public Version Date: 2022-06-06
• Public Version Status: New
• Public Device Record Key: 19f31294-1268-4649-af68-774e41da09c2

Device Description

1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples. a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives. c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative. d. Rehydration Buffer - containing protein stabilizers and preservatives

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
MST	Antibodies, Gliadin	Immunology	866.5750	2
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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 one or 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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08430793040532	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193604	000

Storage Conditions

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