AccessGUDID - DEVICE: SYNCHRON CX® TOTAL PROTEIN REAGENT KIT 88816 (00817302020762)

GUDID

Device Identifier (DI) Information

Brand Name: SYNCHRON CX® TOTAL PROTEIN REAGENT KIT 88816
Version or Model: 88816
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88816
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020762
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: TP (Total Protein) - CX3 Reagent 4 X 1000 Ml

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:	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?
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 [?]
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
Special Storage Condition, Specify: Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
Special Storage Condition, Specify: Reagent is stable on board a clinical analyzer for 30 days
Storage Environment Temperature: between 8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1000 Milliliter
Device Size Text, specify: Kit contains 4 reagent bottles and 1 package insert

Device Record Status

Public Device Record Key: af19a303-8a28-439d-a3f9-a075ba2423df
Public Version Date: August 14, 2023
Public Version Number: 3
DI Record Publish Date: September 01, 2016