CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214 AU-214

GUDID 00817302020946

ALB (Albumin) BCP 3 x 275 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Albumin IVD, reagent
Primary Device ID00817302020946
NIH Device Record Key25fc4cc4-6649-41fb-8869-adb98ee71060
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214
Version Model NumberAU-214
Catalog NumberAU-214
Company DUNS962385787
Company NameCAROLINA LIQUID CHEMISTRIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com

Device Dimensions

Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable on board a clinical analyzer for 30 days

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302020946 [Primary]

FDA Product Code

CJWBROMCRESOL PURPLE DYE-BINDING, ALBUMIN

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 Date2016-09-01

Devices Manufactured by CAROLINA LIQUID CHEMISTRIES CORPORATION

00817302022353 - Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set2023-04-04
00817302022339 - Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN2023-03-20
00817302022346 - Carolina Liquid Chemistries Corp. Fentanyl Detection Kit2023-03-20
00817302024678 - CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC4452022-12-12 Oxidant Reagent (CC445)
00817302024654 - Caldon Biotech Aldolase Reagent2022-12-08 Aldolase
00817302024661 - Caldon Biotech Serum Aldolase Controls2022-12-08 Aldolase Controls
00817302024647 - CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-2402022-10-26 Alkaline Aminotransferase (ALT) (GPT) Reagent
00817302024104 - CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-2202022-08-29 Magnesium Arsenazo Reagent (MG)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.