NMP22 BladderChek Test

GUDID 00811877011538

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.

Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
Primary Device ID00811877011538
NIH Device Record Key6ef81328-3ed8-495a-9ca3-b87e5955f359
Commercial Distribution StatusIn Commercial Distribution
Brand NameNMP22 BladderChek Test
Version Model NumberD1200
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
GS100811877011538 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-16
Device Publish Date2022-08-08

Devices Manufactured by Alere Scarborough, Inc.

10811877010545 - Alere NMP22 Test2023-09-14 For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).
10811877010606 - Alere NMP22 BladderChek Control Kit 2023-09-14 The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control fo
10811877010637 - Alere NMP22® Urine Collection Kit 2023-09-14 The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will b
10811877010798 - DIGIVAL Calibration Check Card Pack2023-09-14 A calibration check card verifies that the DIGIVAL is functioning correctly
00811877011477 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
00811877011507 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
00811877011798 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
10811877010019 - Alere i Influenza A & B 22023-09-12 A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimen

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