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Alere NMP22 BladderChek Test

FDA UDI

Class III (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
Alere NMP22 BladderChek Test FDA UDI
Generic Name
Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical FDA UDI
Device Name
The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. FDA UDI
Model / Reference
D1300 FDA UDI
Description
The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. FDA UDI

Identifiers

Primary DI / UDI-DI
10811877010774 FDA UDI
FDA Product Code
NAH FDA UDI
MMW FDA UDI
GMDN Term
Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
866.6010 FDA UDI
Commercial Distribution
Not 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

Alere NMP22 BladderChek Test by Alere Scarborough, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI a06e148d-3c07-4ce8-b764-c72f7aa35ae4 34 fields · synced Jun 1, 2026