CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 ST321

GUDID 00817302021363

ETHA (Alcohol) w/ cal 2 x 300 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Ethanol (ETOH) IVD, kit, enzyme spectrophotometry Ethanol (ETOH) IVD, kit, enzyme spectrophotometry Ethanol (ETOH) IVD, kit, enzyme spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry Ethanol (ETOH) IVD, kit, spectrophotometry
Primary Device ID00817302021363
NIH Device Record Key022c9d73-06e1-4ee3-9add-05667a0ae643
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321
Version Model NumberST321
Catalog NumberST321
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 Producttrue
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
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
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 Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter
Total Volume5 Milliliter
Device Size Text, specify0
Total Volume33 Milliliter
Total Volume13 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302021363 [Primary]

FDA Product Code

DNNCALIBRATORS, ETHYL ALCOHOL

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.