Lupus Anticoagulant Confirmation Reagent

Basic Information

• Brand Name: Lupus Anticoagulant Confirmation Reagent
• Primary DI: G0561025161
• Version / Model: 102516
• Catalog Number: 102516
• Company Name: Bio/Data Corporation
• Labeler DUNS: 051392959
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-23
• Public Version: 1
• Public Version Date: 2022-03-31
• Public Version Status: New
• Public Device Record Key: 588e7d5c-aad4-476b-b89d-8ec8716e4a5d

Device Characteristics

• Single Use: Yes
• 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: 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
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56202	Lupus anticoagulant marker IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen, using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G0561025161	HIBCC