accutest®

GUDID 10763924070227

ACCUTEST Urine Cotinine Test - cassette format

JANT PHARMACAL CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10763924070227
• NIH Device Record Key: 7c03bec2-bea8-41bc-934e-f1d6d9070d0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: accutest®
• Version Model Number: DS71
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• Device Count: 40
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763924070220 [Unit of Use]
GS1	10763924070227 [Primary]

FDA Product Code

• MRS: Test System, Nicotine, Cotinine, Metabolites

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-24

On-Brand Devices [accutest®]

• 10763924220424: ACCUTEST Buprenorphine drug screen test card - 10 ng/mL
• 10763924208620: ACCUTEST SplitCup-8+6 w. Adulteration Screen (pH/ S.G./ Oxidant/Nit/Glut/Creatinine) (AMP/BAR/BZ
• 10763924135223: Amerinet Choice ACCUTEST Multi-Drug Screen 11-Panel Cassette (AMP, BAR, BZO, COC, TJC, MDMA, OPI
• 10763924134424: accutest MultiDrug Screen-5 COC/M-AMP/MOP(300)/BZO/THC
• 10763924130426: ACCUTEST MD-10(AMP/BARB/BZD/COC/MTDN/M-AMP/MOP/PCP/TCA/THC)
• 10763924106629: ACCUTEST MultiDrug Screen-10+6 (AMP/BARB/BZD/COC/MTDN/M-AMP/OPI/PCP/TCA/THC) w/Adulteration Scr
• 10763924100627: Accutest MultiDrug Screen-10 (AMP/BARB/BZD/COC/MTDN/M-AMP/OPI /PCP/TCA/THC)
• 10763924074423: ACCUTEST MD-9lCOC/AMP/M-AMP/THC/MTD/OPI/PCP/BAR/BZO
• 10763924070227: ACCUTEST Urine Cotinine Test - cassette format
• 10763924061423: accutest MultiDrug Screen 5-panel (AMP/COC/PCP/OPI/THC)
• 10763924060426: accutest MultiDrug Screen 6-panel (AMP/COC/MET/OPI/PCP/THC)
• 10763924056429: ACCUTEST Multi-Drug Screen 6-Panel Cassette Format *CLIA Waived* (AMP, COC, THC, MAMP, OPI, PCP
• 10763924055422: ACCUTEST Multi-Drug Screen NIDA 5-Panel Cassette Format *CLIA Waived* (AMP, COC, THC, OPI, PCP
• 10763924051424: ACCUTEST Multi-Drug Screen 5-Panel Cassette Format *CLIA Waived* (MAMP, COC, THC, AMP, OPI)
• 10763924012623: Accutest-12 Split Cup
• 10763924009623: Accutest SplitCup-6 with Adulteration Screen AMP (300), COC (150,) MDMA (500,) M-AMP (500,) OPI
• 10763924008626: ACCUTEST SplitCup-6+3 w. Adulteration Screen (pH/ S.G./ Oxidant) (AMP1000 /COC 300 /MET 1000/ OP
• 10763924007629: Accutest-10 SplitCup
• 10763924003621: Accutest-5 Split Cup (AMP1000 /COC 300 / OPI 2000/ PCP 25/ THC 50)
• 10763924002624: Accutest-5 Split Cup (AMP1000 /COC 300 /MET 1000/ OPI 2000/ THC 50)
• 10763924001429: accutest MultiDrug Screen- 5 panel (AMP/COC/MET/THC/OPI)