EL-B2GPI IgM, IgG, IgA

Basic Information

• Brand Name: EL-B2GPI IgM, IgG, IgA
• Primary DI: 00854473003040
• Version / Model: 401-404
• Catalog Number: 401-404
• Company Name: THERA-TEST LABORATORIES, INC
• Labeler DUNS: 194336954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 3
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: bb765d63-e2ea-42b9-a69c-b41ac0b07eba

Device Description

ANTI-BETA 2 GLYCOPROTEIN I ANTIBODY ELISA TEST KIT IgM, IgG, IgA, 192 TESTS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
54874	Anticardiolipin-B2-glycoprotein I complex 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 one or multiple classes of antibodies to cardiolipin-B2-glycoprotein I complex 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	00854473003040	GS1

Premarket Submissions

Submission Number	Supplement Number
K092757	000

Storage Conditions

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