Conjugate IgA

Basic Information

• Brand Name: Conjugate IgA
• Primary DI: 07290013348302
• Version / Model: FA233-12M
• Catalog Number: FA233-12M
• Company Name: SAVYON DIAGNOSTICS LTD
• Labeler DUNS: 533708202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-29
• Public Version: 2
• Public Version Date: 2023-08-11
• Public Version Status: Update
• Public Device Record Key: cd808141-9f17-4606-acbd-19b4aa2e2cc8

Device Description

Conjugate IgA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65835	Enzyme immunoassay (EIA) generic reagent kit IVD	A collection of general reagents and other associated materials intended to be used to perform an enzyme immunoassay on clinical specimens; it is not dedicated to the detection of any one type of analyte. It typically consists of an enzyme conjugate, blocking buffer, wash buffer and a substrate solution.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290013348302	GS1

Storage Conditions

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