Healgen

Basic Information

• Brand Name: Healgen
• Primary DI: 00816490021148
• Version / Model: HCDOA-855
• Catalog Number: HCDOA-855
• Company Name: Healgen Scientific Limited Liability Company
• Labeler DUNS: 031802328
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6739be55-91d5-4b55-af7b-f768f4de5904

Device Description

5 Panel DOA Test Clear Round Cup

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20816490021142	GS1	Case	4	In Commercial Distribution
Package	10816490021145	GS1	Inner Pack	25	In Commercial Distribution
Primary	00816490021148	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius