Identity
- Trade Name
- Nano-Check™ OPI Test FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates, in human urine. The detection limit (Cut off concentration) of this test is at 300 ng/ml of morphine. FDA UDI
- Model / Reference
- AD4183 FDA UDI
- Description
- A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates, in human urine. The detection limit (Cut off concentration) of this test is at 300 ng/ml of morphine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00895160002243 FDA UDI
- 510(k) Number
- K050594 FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Commercial Distribution
- 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
Yes
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
Yes
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Nano-Check™ OPI Test by Nano-Ditech Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K050594 also covers:
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA UDI 92934685-0039-4357-a6e3-cd5deb51570f 35 fields · synced Jun 9, 2026