Identity
- Trade Name
- UroMap Specimen Collection Kit FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the probability of T-cell mediated rejection and BK virus nephropathy in kidney transplant patients. The UroMap Specimen collection kit is not intended for home use and is intended to be used by trained medical personnel. FDA UDI
- Model / Reference
- UM-00001 FDA UDI
- Description
- The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the probability of T-cell mediated rejection and BK virus nephropathy in kidney transplant patients. The UroMap Specimen collection kit is not intended for home use and is intended to be used by trained medical personnel. FDA UDI
Identifiers
- Catalog Number
- UM-00001 FDA UDI
- Primary DI / UDI-DI
- 00860193001761 FDA UDI
- FDA Product Code
- OIE FDA UDI
- GMDN Term
- Urine specimen collection kit IVD 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
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: Urine specimen collection kit IVD
UroMap Specimen Collection Kit by Caredx, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 |
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Manufacturer
- Manufacturer
- Caredx, Inc.
Sources (1)
- FDA UDI aecbc896-805e-4aa7-9da1-16724ff6cac8 36 fields · synced Jun 6, 2026