Oral Fluid Amphetamine Calibrator, Intermediate Calibrator

Basic Information

• Brand Name: Oral Fluid Amphetamine Calibrator, Intermediate Calibrator
• Primary DI: B076S0044B0
• Version / Model: S0044b
• Catalog Number: S0044b
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Labeler DUNS: 840839190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-05
• Public Version: 4
• Public Version Date: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: d9677861-fc88-4072-9d4c-8664b31762c7

Device Description

5 mL/bottle. Concentration: 100 ng/mL of Amphetamine.

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
45994	Amphetamine-specific 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 a specific amphetamine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B076S0044B0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K131653	000

Storage Conditions

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