FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® TBIL REAGENT PRODUCT NO. DT228

Primary DI
00817302023084
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® TBIL REAGENT PRODUCT NO. DT228
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
DT228
Catalog number
DT228
Device description
TBIL (Total Bilirubin) 4 x 300 tests
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CIGDIAZO COLORIMETRY, BILIRUBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIGDiazo Colorimetry, BilirubinClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302023084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302023084008173020230848173020230840817302023084

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume12Milliliter
Total Volume68Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Unopened Reagent 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817302022353Carolina Liquid Chemistries Corp. Basic Multi-Drug Control SetCC4492023-03-27
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCLCE11062023-03-10
00817302022346Carolina Liquid Chemistries Corp. Fentanyl Detection KitCLCF650252023-03-10
00817302024678CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445CC445CC4452022-12-03
00817302024654Caldon Biotech Aldolase ReagentCALD-015CALD-0152022-11-30
00817302024661Caldon Biotech Serum Aldolase ControlsCOAL-015COAL-0152022-11-30
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240AU-240AU-2402022-10-18
00817302024104CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220AU-220AU-2202022-08-19
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218AU-240AU-2402022-08-19
00817302024128CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618AU-618AU-6182022-08-19
00817302024135CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621AU-621AU-6212022-08-19
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661AU-661AU-6612022-08-19
00817302024159CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209BL209BL2092022-08-19
00817302024166CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211BL211BL2112022-08-19
00817302024173CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT BL212BL212BL2122022-08-19
00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213BL213BL2132022-08-19
00817302024197CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218BL218BL2182022-08-19
00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220BL220BL2202022-08-19
00817302024210CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240BL240BL2402022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661BL661BL6612022-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336235508Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-02-04
07613336235515Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
07613336235522Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
00630414313429Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313436Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00380740167578ARCHITECTABBOTT IRELANDCIG2024-08-15
04015630924912Bilirubin Direct Gen.2 (Doumas standardization)Roche Diagnostics GmbHCIG2023-10-06
04015630927531Bilirubin Direct Gen.2 (Doumas standardization)Roche Diagnostics GmbHCIG2023-10-06
10673486001204Teco Diagnostics Direct Bilirubin TC-MatrixTECO DIAGNOSTICSCIG2023-07-21
10673486001211Teco Diagnostics Direct Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
10673486001280Teco Diagnostics Total Bilirubin TC MatrixTECO DIAGNOSTICSCIG2023-07-21
10673486001297Teco Diagnostics Total Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
10673486001303Teco Diagnostics Direct and Total Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
00811727015952Pointe Total Bilirubin ReagentPOINTE SCIENTIFIC, INC.CIG2021-01-30
00811727016133Pointe Direct Bilirubin ReagentPOINTE SCIENTIFIC, INC.CIG2021-01-30
00811727016256Pointe Total Bilirubin ReagentPOINTE SCIENTIFIC, INC.CIG2021-01-30
03610230006870Yumizen C1200 Direct BilirubinHORIBA ABX SASCIG2020-08-28
03610230006887Yumizen C1200 Total BilirubinHORIBA ABX SASCIG2020-08-28
00811727015822Pointe Direct Bilirubin for BS480HORIBA INSTRUMENTS INCORPORATEDCIG2020-05-28
00380740174965ARCHITECTAbbott GmbH & Co. KGCIG2020-04-12
00380740174972ARCHITECTAbbott GmbH & Co. KGCIG2020-04-12
07613336164884Direct BilirubinRoche Diagnostics GmbHCIG2020-03-13
07613336121061Bilirubin Direct Gen.2Roche Diagnostics GmbHCIG2020-03-05
07613336121078Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2020-03-05
00380740161828ARCHITECTAbbott GmbH & Co. KGCIG2020-01-04
00386100002039TBIL Reagent KitMEDICA CORPORATIONCIG2019-02-14
00386100002084DBIL Reagent Kit MEDICA CORPORATIONCIG2019-02-14
00380740158415AlinityAbbott GmbH & Co. KGCIG2019-01-02
00380740158422AlinityAbbott GmbH & Co. KGCIG2019-01-02
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSCIG2018-09-21