TOX/See

Basic Information

• Brand Name: TOX/See
• Primary DI: 00847817000348
• Version / Model: 194-5182
• Catalog Number: 1945182
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 132528295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 8
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: a38ed20b-3b75-42c9-95d1-c3aa7cff6e56

Device Description

TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, MTD, OPI, THC

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: Yes
• 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
DJR	ENZYME IMMUNOASSAY, METHADONE	Clinical Toxicology	862.3620	2
DIS	ENZYME IMMUNOASSAY, BARBITURATE	Clinical Toxicology	862.3150	2
JXM	Enzyme immunoassay, benzodiazepine	Clinical Toxicology	862.3170	2
LDJ	ENZYME IMMUNOASSAY, CANNABINOIDS	Clinical Toxicology	862.3870	2
DKZ	ENZYME IMMUNOASSAY, AMPHETAMINE	Clinical Toxicology	862.3100	2
DJG	ENZYME IMMUNOASSAY, OPIATES	Clinical Toxicology	862.3650	2
LFG	RADIOIMMUNOASSAY, TRICYCLIC ANTIDEPRESSANT DRUGS	Clinical Toxicology	862.3910	2
JXN	ENZYME IMMUNOASSAY, PROPOXYPHENE	Clinical Toxicology	862.3700	2
DJC	Thin layer chromatography, methamphetamine	Clinical Toxicology	862.3610	2
LCM	Enzyme immunoassay, phencyclidine	Unknown		U
DIO	ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES	Clinical Toxicology	862.3250	2

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
Primary	00847817000348	GS1

Customer Contacts

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

Storage Conditions

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