Identity
- Trade Name
- OSTS FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MDMA/MET500/MTD/MOR300/OXY/PCP/TCA/THC/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25 tests/kit FDA UDI
- Model / Reference
- 712M05A-OS FDA UDI
- Description
- 13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MDMA/MET500/MTD/MOR300/OXY/PCP/TCA/THC/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25 tests/kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850019007930 FDA UDI
- 510(k) Number
- K142396 FDA UDI
- FDA Product Code
- DJR FDA UDIDJC FDA UDIDIS FDA UDIJXM FDA UDILDJ FDA UDILCM FDA UDILAF FDA UDIDIO FDA UDIDKZ FDA UDIDJG FDA UDILFG FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI862.3610 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3870 FDA UDI862.3250 FDA UDI862.3100 FDA UDI862.3650 FDA UDI862.3910 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Osts 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
K142396 also covers:
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — Chemtron Biotech, Inc.
- Chemtrue — 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 320cc717-a144-402d-84ee-50cffea4ac7f 34 fields · synced May 30, 2026