Identity
- Trade Name
- NMP22 BladderChek Control Kit FDA UDI
- Generic Name
- Nuclear matrix protein 22 IVD, control FDA UDI
- Device Name
- NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the NMP22 BladderChek Test. FDA UDI
- Model / Reference
- D1250 FDA UDI
- Description
- NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the NMP22 BladderChek Test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811877011552 FDA UDI
- 510(k) Number
- K021231 FDA UDI
- FDA Product Code
- MMW FDA UDI
- GMDN Term
- Nuclear matrix protein 22 IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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
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, control
NMP22 BladderChek Control Kit by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 6db59424-2a8c-41c1-ab96-d74c39aeb663 34 fields · synced May 30, 2026