Identity
- Trade Name
- KidneyCare Specimen Collection Kit FDA UDI
- Generic Name
- Phlebotomy kit FDA UDI
- Device Name
- Convenience mobile phlebotomy sample collection kit FDA UDI
- Model / Reference
- AS-00005 FDA UDI
- Description
- Convenience mobile phlebotomy sample collection kit FDA UDI
Identifiers
- Catalog Number
- AS-00005 FDA UDI
- Primary DI / UDI-DI
- 00860193001747 FDA UDI
- FDA Product Code
- OFZ FDA UDI
- GMDN Term
- Phlebotomy kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.1100 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
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Phlebotomy kit
KidneyCare Specimen Collection Kit by Caredx, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phlebotomy kit.
- Aero-Med — AERO-MED LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · N
- Aero-Med — AERO-MED LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Aero-Med — AERO-MED LLC · Class I
- Aero-Med — AERO-MED LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Aero-Med — AERO-MED LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Caredx, Inc.
Sources (1)
- FDA UDI b8ba872e-7a8f-4dee-89f9-1d93594bd6cc 36 fields · synced Jun 8, 2026