Total Protein Reagent 501-416

GUDID 00812137012036

For the quantitative determination of total protein concentration in serum.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Total protein IVD, reagent
Primary Device ID00812137012036
NIH Device Record Key1091e959-cbd4-47e1-8c28-7938776184da
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Protein Reagent
Version Model Number500mL
Catalog Number501-416
Company DUNS048144997
Company NameCLINICAL DIAGNOSTIC SOLUTIONS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812137012036 [Primary]

FDA Product Code

CEKBiuret (Colorimetric), Total Protein

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-12

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