Oral Fluid 6-Acetylmorphine Enzyme Immunoassay

Basic Information

• Brand Name: Oral Fluid 6-Acetylmorphine Enzyme Immunoassay
• Primary DI: B076S02910
• Version / Model: S0291
• Catalog Number: S0291
• 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: b1b4d0be-5818-4e5f-867a-e8fdde7f66c8

Device Description

Large Test Kit. Antibody/Substrate Reagent (R1): 750 mL. Enzyme Conjugate Reagent (R2): 375 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
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61891	6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 6-acetyl morphine in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B076S02910	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K141205	000

Storage Conditions

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