Identity
- Trade Name
- Chemtrue FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Chemtrue 5-Panel DOA Cup, AMP500/COC150/MET500/OPI/PCP/(Cr/SG/Ox/Ni/pH/Gl) FDA UDI
- Model / Reference
- 712E14-CT FDA UDI
- Description
- Chemtrue 5-Panel DOA Cup, AMP500/COC150/MET500/OPI/PCP/(Cr/SG/Ox/Ni/pH/Gl) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812203030551 FDA UDI
- 510(k) Number
- K153192 FDA UDI
- FDA Product Code
- DIO FDA UDIDJC FDA UDIDKZ FDA UDIDJG FDA UDILCM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 FDA UDI862.3610 FDA UDI862.3100 FDA UDI862.3650 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
Yes
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue by Chemtron Biotech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153192 also covers:
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- DrugSmart Cup — Chemtron Biotech, Inc.
- DrugSmart Cup — Chemtron Biotech, Inc.
- DrugSmart Cup 7 — Chemtron Biotech, Inc.
- DrugSmart Cup 9 — Chemtron Biotech, Inc.
- Generic — Chemtron Biotech, Inc.
- OSTS — Chemtron Biotech, Inc.
- Premier Biotech — Chemtron Biotech, Inc.
- Premier Biotech — Chemtron Biotech, Inc.
- Premier Biotech — Chemtron Biotech, 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
- Chemtron Biotech, Inc.
Sources (1)
- FDA UDI c87988e7-3e8d-4acc-b589-1c1393b5e46c 34 fields · synced Jun 1, 2026