AccessGUDID - DEVICE: QuanTtest Red Pyrogallol Red Reagent (00896863002349)

GUDID

Device Identifier (DI) Information

Brand Name: QuanTtest Red Pyrogallol Red Reagent
Version or Model: 5210-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5210-12
Company Name: QUANTIMETRIX CORPORATION

Primary DI Number: 00896863002349
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010717890 *Terms of Use
Previous DI: M0515210120

Device Description: QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems.

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):	No
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?
53989	Total protein 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 quantitative measurement of total protein in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEK	Biuret (Colorimetric), Total Protein

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K904603	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d2450c4-c462-4f2b-a579-6199c884aca3
Public Version Date: October 07, 2019
Public Version Number: 1
DI Record Publish Date: September 27, 2019