AccessGUDID - DEVICE: Alere NMP22 Test (10811877010545)

GUDID

Device Identifier (DI) Information

Brand Name: Alere NMP22 Test
Version or Model: D1100E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alere Scarborough, Inc.

Primary DI Number: 10811877010545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154148498 *Terms of Use

Device Description: For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).

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):	No
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?
60571	Nuclear matrix protein 22 IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nuclear matrix protein 22 (NMP22) [also known as nuclear mitotic apparatus protein 1] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of urological conditions (e.g., bladder cancer, prostate cancer).	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P940035	000

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: 12c8f072-32e6-49b0-91ab-6b28ac2a6fd2
Public Version Date: February 05, 2024
Public Version Number: 4
DI Record Publish Date: September 01, 2014