AccessGUDID - DEVICE: NA (10858512007003)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 301-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 301-1
Company Name: ALTA DIAGNOSTICS INC

Primary DI Number: 10858512007003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 859323297 *Terms of Use

Device Description: Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
30219	Multiple urine analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJW	Urinalysis Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K890577	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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Milliliter

Device Record Status

Public Device Record Key: 3b1b8531-fca9-412c-8c8e-b0ccfc18a712
Public Version Date: April 08, 2019
Public Version Number: 1
DI Record Publish Date: March 29, 2019