CRYOcheck™ LA Check™

Basic Information

• Brand Name: CRYOcheck™ LA Check™
• Primary DI: 00843876000459
• Version / Model: CHK-40
• Company Name: Precision Biologic Inc
• Labeler DUNS: 244713368
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 81
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-04-07
• Public Version Status: Update
• Public Device Record Key: 912ce76e-6933-4789-925b-97d85bf53ce9
• Distribution End Date: 2023-03-01

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: 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
GIR	Reagent, Russel Viper Venom	Hematology	864.8950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56203	Lupus anticoagulant marker IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843876000459	GS1
Unit of Use	00843876010458	GS1

Premarket Submissions

Submission Number	Supplement Number
K990579	000