Identity
- Trade Name
- Kidney Combo Test Kit 1 FDA UDI
- Generic Name
- Phlebotomy kit FDA UDI
- Device Name
- ncludes tests for both urine and blood markers related to kidney function FDA UDI
- Model / Reference
- KHK01 FDA UDI
- Description
- ncludes tests for both urine and blood markers related to kidney function FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013969509 FDA UDI
- FDA Product Code
- OIB FDA UDI
- GMDN Term
- Phlebotomy kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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: Phlebotomy kit
Kidney Combo Test Kit 1 by Ditek Consulting Llc — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ditek Consulting Llc
Sources (1)
- FDA UDI 79ca8a95-5d6e-4cb1-9083-e32dbdcc3467 33 fields · synced May 31, 2026