AccessGUDID - DEVICE: Alere NMP22 BladderChek Test (10811877010774)

GUDID

Device Identifier (DI) Information

Brand Name: Alere NMP22 BladderChek Test
Version or Model: D1300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alere Scarborough, Inc.

Primary DI Number: 10811877010774
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 154148498 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60572	Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of nuclear matrix protein 22 (NMP22) [also known as nuclear mitotic apparatus protein 1] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses typically to aid in the diagnosis of urological conditions (e.g., bladder cancer, prostate cancer). It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAH	System, Test, Tumor Marker, For Detection Of Bladder Cancer
MMW	System, Test, Tumor Marker, Monitoring, Bladder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a06e148d-3c07-4ce8-b764-c72f7aa35ae4
Public Version Date: February 05, 2024
Public Version Number: 5
DI Record Publish Date: September 01, 2014