Methadone Metabolite 100 Semi-Quantitative Calibrators Set

Basic Information

• Brand Name: Methadone Metabolite 100 Semi-Quantitative Calibrators Set
• Primary DI: 00850624008193
• Version / Model: 08735603190
• Catalog Number: 08735603190
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Labeler DUNS: 840839190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 1
• Public Version Date: 2019-02-18
• Public Version Status: New
• Public Device Record Key: 340a0a72-2cb9-4fbe-9397-15b422d49207

Device Description

EDDP 100 Negative Calibrator 0 ng/mL (1 x 5 mL), EDDP 100 Low Calibrator 50 ng/mL (1 x 5 mL), EDDP 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL), EDDP 100 Intermediate Calibrator 250 ng/mL (1 x 5 mL), EDDP 100 High Calibrator 500 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
43638	2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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 the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850624008193	GS1

Storage Conditions

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