Immunalysis Corporation

Basic Information

• Brand Name: Immunalysis Corporation
• Primary DI: 00840937108291
• Version / Model: 10008-5
• Company Name: IMMUNALYSIS CORPORATION
• Labeler DUNS: 080589004
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 5
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: f09d43a2-030a-47dc-a4c9-965f8ccff87a

Device Description

Opiates Urine Calibrator 2000 Level 2 - 1000 ng/mL (5 mL)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
55722	Opiate/opiate metabolite 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 opiate and/or opiate metabolites in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840937108291	GS1

Storage Conditions

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