FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224

Primary DI
00817302020182
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
BL-224.
Catalog number
BL-224.
Device description
ALB (Albumin) 3 X 160 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
CIXBROMCRESOL GREEN DYE-BINDING, ALBUMIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIXBromcresol Green Dye-Binding, AlbuminClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302020182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020182008173020201828173020201820817302020182

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of albumin in a clinical specimen, using an enzyme spectrophotometry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume40Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reagent is stable on board a clinical analyzer for 30 days
Special Storage Condition, Specify00Reagent is stable until expiration date on kit when stored at 8 to 30°
Storage Environment Temperature8 Degrees Celsius30 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
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
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
00817302021257CAROLINA LIQUID CHEMISTRIES CORP.® COCM RGT. KIT AU-413AU-413AU-4132016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654140Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2026-03-18
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
00380740155346AlinityABBOTT IRELANDCIX2024-08-15
00380740155353AlinityABBOTT IRELANDCIX2024-08-15
00380740155872ARCHITECTABBOTT IRELANDCIX2024-08-15
00380740155889ARCHITECTABBOTT IRELANDCIX2024-08-15
00850053916007IDG/SanzayIDG/SANZAY CorporationCIX2023-12-18
10673486001013Albumin Reagent SetTECO DIAGNOSTICSCIX2023-07-07
10673486001020Albumin -BCG method TC-MatrixTECO DIAGNOSTICSCIX2023-07-07
00811727016003Pointe Albumin Reagent HORIBA INSTRUMENTS INCORPORATEDCIX2021-01-30
00811727015693Pointe Albumin on BS480 AnalyzerHORIBA INSTRUMENTS INCORPORATEDCIX2020-05-28
10758750031771VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CIX2020-05-16
03610230006825Yumizen C1200 AlbuminHORIBA ABX SASCIX2020-05-06
07613336120941Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
07613336120958Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
00380740161644ARCHITECTAbbott GmbHCIX2019-11-15
00386100002145ALB Reagent KitMEDICA CORPORATIONCIX2019-02-14
00380740121716AlinityAbbott GmbHCIX2018-07-11
00852169008010ClearChem Diagnostics Inc. AlbuminCLEARCHEM DIAGNOSTICS INC.CIX2018-04-30
00817274022696JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2018-04-26
00630414596501Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2017-12-22
05060500091682Synermed®INFRARED LABORATORY SYSTEMS LLCCIX2017-02-28
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224CAROLINA LIQUID CHEMISTRIES CORPORATIONCIX2016-10-17
00812137011848Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00081213701184Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00817274022313JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2016-10-11
00817439020093Albumin / BS480Medtest Dx, Inc.CIX2016-09-27