Identity
- Trade Name
- Alere NMP22® Urine Collection Kit FDA UDI
- Generic Name
- Nuclear matrix protein 22 IVD, reagent FDA UDI
- Device Name
- The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will be tested using the Alere NMP22® (ELISA)Test Kit . FDA UDI
- Model / Reference
- D2100E FDA UDI
- Description
- The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will be tested using the Alere NMP22® (ELISA)Test Kit . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010637 FDA UDI
- PMA Number
- P940035 FDA UDI
- FDA Product Code
- NAH FDA UDI
- GMDN Term
- Nuclear matrix protein 22 IVD, reagent FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nuclear matrix protein 22 IVD, reagent
Alere NMP22® Urine Collection Kit by Alere Scarborough, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P940035 also covers:
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI ea64e6cd-4cbb-45ce-95dc-5be1bfa3eb47 34 fields · synced May 30, 2026