US Biotek Laboratories

Basic Information

• Brand Name: US Biotek Laboratories
• Primary DI: 00860010959268
• Version / Model: 1.0
• Catalog Number: SCK001
• Company Name: U.S. Biotek Laboratories LLC
• Labeler DUNS: 094709776
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: 61455468-b475-44b7-9454-f6f0ea023086

Device Description

Single-use convenient serum collection kit includes collection tube(s), and return packing for mailing to testing laboratory.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42368	Evacuated blood collection tube IVD, clot promoter	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood clot promoter (e.g., thrombin). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., rapid serum chemistry determinations). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010959268	GS1