Identity
- Trade Name
- Alere NMP22 Test FDA UDI
- Generic Name
- Nuclear matrix protein 22 IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA). FDA UDI
- Model / Reference
- D1100E FDA UDI
- Description
- For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010545 FDA UDI
- PMA Number
- P940035 FDA UDI
- FDA Product Code
- NAH FDA UDI
- GMDN Term
- Nuclear matrix protein 22 IVD, kit, enzyme immunoassay (EIA) 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, kit, enzyme immunoassay (EIA)
Alere NMP22 Test 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 |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 12c8f072-32e6-49b0-91ab-6b28ac2a6fd2 34 fields · synced May 30, 2026