Identity
- Trade Name
- LifeSign QuikScreen 11 FDA UDI
- Generic Name
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
- Device Name
- LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/ml Phencyclidine (PCP) 25 ng/ml Methamphetamine (MET) 1000 ng/ml Opiate (OPI) 2000 ng/ml Barbiturates (BAR) 300 ng/ml Benzodiazepine (BZD) 300 ng/ml Marijuana (THC) 50 ng/ml Methadone (MAD) 300 ng/ml Oxycodone (OXY) 100 ng/ml Tricyclic Antidepressants (TCA) 1000 ng/ml Cocaine (COC) 300ng/ml FDA UDI
- Model / Reference
- 60B02 FDA UDI
- Description
- LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/ml Phencyclidine (PCP) 25 ng/ml Methamphetamine (MET) 1000 ng/ml Opiate (OPI) 2000 ng/ml Barbiturates (BAR) 300 ng/ml Benzodiazepine (BZD) 300 ng/ml Marijuana (THC) 50 ng/ml Methadone (MAD) 300 ng/ml Oxycodone (OXY) 100 ng/ml Tricyclic Antidepressants (TCA) 1000 ng/ml Cocaine (COC) 300ng/ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863480002106 FDA UDI
- 510(k) Number
- K071489 FDA UDI
- FDA Product Code
- DJG FDA UDILFH FDA UDIDJR FDA UDIDJC FDA UDILDJ FDA UDIDIO FDA UDIJXM FDA UDIDIS FDA UDIDKZ FDA UDI
- GMDN Term
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3910 FDA UDI862.3620 FDA UDI862.3610 FDA UDI862.3870 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3150 FDA UDI862.3100 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
LifeSign QuikScreen 11 by Lifesign L.L.C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K071489 also covers:
- ACCUTEST - 5 Drug Test Cup *CLIA-Waived* — JANT PHARMACAL CORP.
- ACCUTEST - 6 Drug Cup — JANT PHARMACAL CORP.
- ACCUTEST Drug Test Cup 11-Panel CLIA-Waived — JANT PHARMACAL CORP.
- Status Toxi Cup — Lifesign L.L.C.
- QTEST 11 (25 pack) — MEDIMPEX UNITED, INC
- QTEST 12 (25 Pack) — MEDIMPEX UNITED, INC
- QTEST 5 (25 Pack) — MEDIMPEX UNITED, INC
- QTEST 7 (25 Pack) — MEDIMPEX UNITED, INC
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lifesign L.L.C.
Sources (1)
- FDA UDI 8300f52e-0d02-4ace-9b70-b0771deec64e 35 fields · synced May 30, 2026