ClearChem Diagnostics Inc. Protein, Total TPR1310

GUDID 00852169008249

In Vitro Diagnostics testing kit R1:4X60mL

CLEARCHEM DIAGNOSTICS INC.

Total protein IVD, reagent
Primary Device ID00852169008249
NIH Device Record Keyd2e38c9f-c079-4263-841b-782f6bbacf07
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearChem Diagnostics Inc. Protein, Total
Version Model NumberTPR1310
Catalog NumberTPR1310
Company DUNS010655581
Company NameCLEARCHEM DIAGNOSTICS INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Phone+1(714)734-8041
Emaildwheat@clearchem.net

Device Dimensions

Total Volume240 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852169008249 [Primary]

FDA Product Code

CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-31
Device Publish Date2018-04-30

Devices Manufactured by CLEARCHEM DIAGNOSTICS INC.

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00852169008164 - ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol2018-06-18 In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
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