Twelve Panel PreScreen Plus Mini Cup (CLIA Waived)

Basic Information

• Brand Name: Twelve Panel PreScreen Plus Mini Cup (CLIA Waived)
• Primary DI: 00851000007205
• Version / Model: PSC-DOA-6125M
• Company Name: MERGERS MARKETING, INC.
• Labeler DUNS: 065602744
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-07
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: f45d575d-5bb5-405b-af63-3fe0dd342ba5

Device Description

Twelve Panel PreScreen Mini Plus Cup (CLIA Waived) Drug Combo: AMP|BAR|BUP|BZO|COC|MAMP|MDMA|OPI300|MTD|OXY|PCP|THC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	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
Package	10851000007219	GS1	Case	4	In Commercial Distribution
Package	00851000007212	GS1	Inner Pack	25	In Commercial Distribution
Primary	00851000007205	GS1