FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT KIT Product No. DT421

Primary DI
00817302021851
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT KIT Product No. DT421
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
DT421
Catalog number
DT421
Device description
ETHA (Alcohol) w/ cal 2 x 500 tests
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DMTENZYMATIC METHOD, ALCOHOL DEHYDROGENASE, ULTRAVIOLET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DMTEnzymatic Method, Alcohol Dehydrogenase, UltravioletClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302021851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302021851008173020218518173020218510817302021851

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen, using an enzyme spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume5Milliliter
Total Volume46.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)471-7272ContactSales@CarolinaChemistries.com

Regulatory Flags#

DUNS number
962385787
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817302020274CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227ST227ST2272016-09-01
00817302020281CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT BL-227BL227BL2272016-09-01
00817302020298CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT AU-227AU-227AU-2272016-09-01
00817302020304CAROLINA LIQUID CHEMISTRIES CORP.™ AMY AMYLASE REAGENT CC227CC227CC2272016-09-01
00817302022964CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227DT227DT2272016-10-17
00817302020182CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224BL-224.BL-224.2016-09-01
00817302020199CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALBUMIN REAGENT KIT Product No. ST224ST224ST2242016-09-01
00817302020205CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224AU-224AU-2242016-09-01
00817302020212CAROLINA LIQUID CHEMISTRIES CORP.® ALB (BCG) CC224CC224CC2242016-09-01
00817302020229CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214CC214CC2142016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214AU-214AU-2142016-09-01
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224DT224DT2242016-10-17
00817302021912CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT BL-419BBL419BBL419B2016-09-01
00817302020786CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT BL-425BL425BL4252016-09-01
00817302020809CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425AU-425AU-4252016-09-01
00817302020816CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425DT425DT4252016-09-01
00817302020847CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424AU-424AU-4242016-09-01
00817302021066CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT AU-412AU-412AU-4122016-09-01
00817302021127CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT AU-417AU-417AU-4172016-09-01
00817302021189CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT. KIT AU-418AU-418AU-4182016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942284613443femometerJOYTECH HEALTHCARE CO.,LTDDMT2026-05-25
00380740135393AlinityABBOTT LABORATORIESDMT2019-04-16
00380740135386AlinityABBOTT LABORATORIESDMT2018-07-11
00884883012486DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-22
00884883001008DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-12
00884883002890DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-12
15099590223335SynchronBeckman Coulter, Inc.DMT2016-08-24
10758750004270VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DMT2016-08-23
00380740005559ARCHITECTABBOTT LABORATORIESDMT2016-06-06