Buprenorphine Semi-Quantitative Calibrators Set

Basic Information

• Brand Name: Buprenorphine Semi-Quantitative Calibrators Set
• Primary DI: 00850624008100
• Version / Model: 08239886190
• Catalog Number: 08239886190
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Labeler DUNS: 840839190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-20
• Public Version: 4
• Public Version Date: 2018-10-15
• Public Version Status: Update
• Public Device Record Key: a73aaca9-c4a1-4f4a-a6df-24980bf8619a

Device Description

BUP Negative Calibrator 0 ng/mL (1 x 5 mL), BUP Low/Cutoff Calibrator #1 5 ng/mL (1 x 5 mL), BUP Cutoff Calibrator #2 10 ng/mL (1 x 5 mL), BUP Intermediate Calibrator #1 20 ng/mL (1 x 5 mL), BUP Intermediate Calibrator #2 40 ng/mL (1 x 5 mL), BUP High Calibrator 75 ng/mL (1 x 5 mL).

Device Characteristics

• Single Use: No
• 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
DLJ	Calibrators, Drug Specific	Clinical Toxicology	862.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42691	Buprenorphine IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of buprenorphine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850624008100	GS1

Storage Conditions

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