NMP22 BladderChek Control Kit

GUDID 00811877011552

NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the NMP22 BladderChek Test.

Alere Scarborough, Inc.

Nuclear matrix protein 22 IVD, control
Primary Device ID00811877011552
NIH Device Record Key6db59424-2a8c-41c1-ab96-d74c39aeb663
Commercial Distribution StatusIn Commercial Distribution
Brand NameNMP22 BladderChek Control Kit
Version Model NumberD1250
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
GS100811877011552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMWSystem, Test, Tumor Marker, Monitoring, Bladder

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
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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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