QTEST 7 (25 Pack)

GUDID 10864040000324

Qtest 7 (25 Pack) - AMP 1000, BZD 300, COC 300, MET 1000, OPI 2000, OXY 100, THC 50

MEDIMPEX UNITED, INC

Drug/toxicology screen adulteration IVD, kit,rapid enzyme spectrophotometry, clinical

• Primary Device ID: 10864040000324
• NIH Device Record Key: eebfdd91-6273-49e6-b1fe-bd49b7db9da2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QTEST 7 (25 Pack)
• Version Model Number: DOA-7QT
• Company DUNS: 130991479
• Company Name: MEDIMPEX UNITED, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	10864040000324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071489

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-30

Devices Manufactured by MEDIMPEX UNITED, INC

• 10864040000317 - QTEST 5 (25 Pack): 2022-11-28 Qtest 5 (25 pack) - AMP 1000, COC 300, MET 1000, OPI 2000,THC 50
• 10864040000324 - QTEST 7 (25 Pack): 2022-11-28Qtest 7 (25 Pack) - AMP 1000, BZD 300, COC 300, MET 1000, OPI 2000, OXY 100, THC 50
• 10864040000324 - QTEST 7 (25 Pack): 2022-11-28 Qtest 7 (25 Pack) - AMP 1000, BZD 300, COC 300, MET 1000, OPI 2000, OXY 100, THC 50
• 10864040000331 - QTEST 11 (25 pack): 2022-11-28 Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50
• 10864040000348 - QTEST 12 (25 Pack): 2022-11-28 Qtest 12 (25 pack) - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 5