Identity
- Trade Name
- Oratect Oral Fluid Collection Tube FDA UDI
- Generic Name
- Drug-testing specimen collection kit IVD FDA UDI
- Device Name
- Oral Fluid Specimen Collection Tube FDA UDI
- Model / Reference
- CM-190 FDA UDI
- Description
- Oral Fluid Specimen Collection Tube FDA UDI
Identifiers
- Catalog Number
- CM-190 FDA UDI
- Primary DI / UDI-DI
- 00816565020847 FDA UDI
- 510(k) Number
- K103227 FDA UDI
- FDA Product Code
- LCM FDA UDIDJG FDA UDIDKZ FDA UDIDIO FDA UDILDJ FDA UDIDJC FDA UDI
- GMDN Term
- Drug-testing specimen collection kit IVD FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3100 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3610 FDA UDI
- Commercial Distribution
- Not 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
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
Oratect Oral Fluid Collection Tube by Ameditech Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K103227 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 | Class U | Pending data |
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Manufacturer
- Manufacturer
- Ameditech Inc.
Sources (1)
- FDA UDI 201ec915-6e8e-40d9-abaf-d391a276c33a 38 fields · synced May 30, 2026