Identity
- Trade Name
- CRL STAT Dip Card FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- CRL STAT 8 Panel Dip - KCUR920121 AMP1000/BAR300/BZO300/COC300/MET1000/OPI2000/PCP25/THC50 (CR/NI/OX/PH/SG) FDA UDI
- Model / Reference
- KCUR920121 FDA UDI
- Description
- CRL STAT 8 Panel Dip - KCUR920121 AMP1000/BAR300/BZO300/COC300/MET1000/OPI2000/PCP25/THC50 (CR/NI/OX/PH/SG) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817815020907 FDA UDI
- FDA Product Code
- DKZ FDA UDIDIS FDA UDIJXM FDA UDIDIO FDA UDILAF FDA UDIDJG FDA UDILCM FDA UDILDJ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3610 FDA UDI862.3650 FDA UDI862.3870 FDA UDI
- 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
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
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT Dip Card by Clinical Reference Laboratory, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Clinical Reference Laboratory, Inc.
Sources (1)
- FDA UDI 28cc4a80-6712-42a4-ab5d-8e92388b2d54 33 fields · synced May 31, 2026