Identity
- Trade Name
- SpeciMAX Dx Saliva Collection Kit FDA UDI
- Generic Name
- Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
- Device Name
- SPECIMAX SALIVA KIT, IVD FDA UDI
- Model / Reference
- A51022 FDA UDI
- Description
- SPECIMAX SALIVA KIT, IVD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302016858 FDA UDI
- FDA Product Code
- KDT FDA UDI
- GMDN Term
- Oral/respiratory tract specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
SpeciMAX Dx Saliva Collection Kit by Life Technologies Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Limited
Sources (1)
- FDA UDI 2ad6e7b9-6f02-4525-9fd1-853344500417 34 fields · synced Jun 1, 2026