IDK® sIgA ELISA

Basic Information

• Brand Name: IDK® sIgA ELISA
• Primary DI: 04050598010451
• Version / Model: K 8870.US
• Company Name: Immundiagnostik AG
• Labeler DUNS: 321663841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-21
• Public Version: 1
• Public Version Date: 2023-06-29
• Public Version Status: New
• Public Device Record Key: 12609bcf-f9b8-457b-ab87-48498b9b854a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
DAJ	Free Secretory Component, Antigen, Antiserum, Control	Immunology	866.5380	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53763	Secretory immunoglobulin A (secretory IgA) 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 secretory immunoglobulin A (secretory IgA) 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	04050598010451	GS1

Storage Conditions

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