Alere NMP22 BladderChek Test

GUDID 10811877010774

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.

Alere Scarborough, Inc.

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Primary Device ID10811877010774
NIH Device Record Keya06e148d-3c07-4ce8-b764-c72f7aa35ae4
Commercial Distribution Discontinuation2015-10-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAlere NMP22 BladderChek Test
Version Model NumberD1300
Company DUNS154148498
Company NameAlere Scarborough, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110811877010774 [Primary]

FDA Product Code

NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2014-09-01

On-Brand Devices [Alere NMP22 BladderChek Test]

10811877010774The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detecti
10811877010569The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detecti
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