Identity
- Trade Name
- OSTS FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- OSTS 11-Panel DOA Dip Test AMP500/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR/OXY/PCP FDA UDI
- Model / Reference
- 711K04-OS FDA UDI
- Description
- OSTS 11-Panel DOA Dip Test AMP500/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR/OXY/PCP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812203030377 FDA UDI
- 510(k) Number
- K153192 FDA UDI
- FDA Product Code
- LAF FDA UDILCM FDA UDIDJR FDA UDIDJC FDA UDIDIO FDA UDIJXM FDA UDIDJG FDA UDIDIS FDA UDIDKZ FDA UDIDNK FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3610 FDA UDI862.3620 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3650 FDA UDI862.3150 FDA UDI862.3100 FDA UDI862.3640 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
No
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
K153192 also covers:
- Chemtrue — Chemtron Biotech, Inc.
- 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.
- 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 7674598e-713c-41a8-b3e3-c38fc260b60c 35 fields · synced May 31, 2026