ClearChem Diagnostics Inc. TIBC-Direct ITI1160

GUDID 00852169008232

In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL

CLEARCHEM DIAGNOSTICS INC.

Total iron binding capacity IVD (TIBC), reagent
Primary Device ID00852169008232
NIH Device Record Key7eebb6fb-bb71-471e-9f92-2f7acc801337
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearChem Diagnostics Inc. TIBC-Direct
Version Model NumberITI1160
Catalog NumberITI1160
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 Volume144 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
GS100852169008232 [Primary]

FDA Product Code

JMOFerrozine (colorimetric) iron binding capacity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-22
Device Publish Date2018-05-22

Devices Manufactured by CLEARCHEM DIAGNOSTICS INC.

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00852169008294 - ClearChem Diagnostics Inc. MicroProtein, Total2018-07-09 In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL
00852169008232 - ClearChem Diagnostics Inc. TIBC-Direct2018-06-22In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL
00852169008232 - ClearChem Diagnostics Inc. TIBC-Direct2018-06-22 In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL
00852169008270 - ClearChem Diagnostics Inc. MicroAlbumin2018-06-22 In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL
00852169008287 - ClearChem Diagnostics Inc. Hemoglobin A-1c2018-06-22 In Vitro Diagnostics testing kit Buffer:1X36mL, R1a:1X16mL, R2b:1X6.7mL, R2:1X10.1mL
00852169008058 - ClearChem Diagnostics Inc. Aspartate aminotransferase (AST)2018-06-18 In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL
00852169008164 - ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol2018-06-18 In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
00852169008072 - ClearChem Diagnostics Inc. Carbon Dioxide (CO2)2018-06-11 In Vitro Diagnostics testing kit R1:6X30mL

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