Identity
- Trade Name
- Color Saliva Collection Kit FDA UDI
- Generic Name
- Specimen stabilization reagent IVD FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860014139307 FDA UDI
- FDA Product Code
- OYJ FDA UDI
- GMDN Term
- Specimen stabilization reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral/respiratory tract specimen container IVD, additive/mediumSpecimen stabilization reagent IVD
Color Saliva Collection Kit by Color Diagnostics, Llc — 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
- Color Diagnostics, Llc
Sources (1)
- FDA UDI 8987753a-400a-4444-ae8c-afefd17e352c 32 fields · synced Jun 1, 2026