AccessGUDID - DEVICE: Alere NMP22® Urine Collection Kit (10811877010637)

GUDID

Device Identifier (DI) Information

Brand Name: Alere NMP22® Urine Collection Kit
Version or Model: D2100E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alere Scarborough, Inc.

Primary DI Number: 10811877010637
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154148498 *Terms of Use

Device Description: The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will be tested using the Alere NMP22® (ELISA)Test Kit .

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?
60575	Nuclear matrix protein 22 IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nuclear matrix protein 22 in a clinical specimen.	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: ea64e6cd-4cbb-45ce-95dc-5be1bfa3eb47
Public Version Date: September 14, 2023
Public Version Number: 3
DI Record Publish Date: September 01, 2014