FDA.report

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CA RGT KIT Product No. ST251

Primary DI
00817302020403
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CA RGT KIT Product No. ST251
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
ST251
Catalog number
ST251
Device description
CA (Calcium) 4 x 200 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CJYAZO DYE, CALCIUM

Product Code Classifications

CodeDeviceSpecialtyClass
CJYAzo Dye, CalciumClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817302020403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020403008173020204038173020204030817302020403

GMDN Terms

TermDefinition
Calcium (Ca2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of calcium (Ca2+) in a clinical specimen, using a spectrophotometry method.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume57Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

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
false
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 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 DIBrandCompanyProduct codePublished
03610230008607Yumizen C1200 Calcium ASHORIBA ABX SASCJY2020-05-06
00380740161491ARCHITECTAbbott GmbH & Co. KGCJY2020-03-09
00380740161507ARCHITECTAbbott GmbH & Co. KGCJY2020-03-09
00380740161514ARCHITECTAbbott GmbH & Co. KGCJY2020-03-09
05055273208368CALCIUM (Ca)RANDOX LABORATORIES LIMITEDCJY2019-06-03
00386100002060Ca Reagent Kit MEDICA CORPORATIONCJY2019-02-14
00630414220697Atellica CH CA_2Siemens Healthcare Diagnostics Inc.CJY2018-09-24
00380740135409AlinityAbbott GmbH & Co. KGCJY2018-08-31
00380740132613AlinityAbbott GmbH & Co. KGCJY2018-08-08
00817274022450JAS DiagnosticsDREW SCIENTIFIC, INC.CJY2017-04-04
05060500091835Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2017-02-28
00817302023091CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251CAROLINA LIQUID CHEMISTRIES CORPORATIONCJY2016-10-17
15099590000325AUBeckman Coulter, Inc.CJY2016-09-24
15099590011086AUBeckman Coulter, Inc.CJY2016-09-24
15099590060183AUBeckman Coulter, Inc.CJY2016-09-24
00857969006105ACEALFA WASSERMANN, INC.CJY2016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414553160ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo IIISiemens Healthcare Diagnostics Inc.CJY2016-09-24
00657498000618Calcium (Arsenazo) LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23
00657498001462Sirrus® Calcium LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23
05060500090463Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2016-09-20
05060500090470Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2016-09-20
05060500090487Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2016-09-20
05060500090494Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2016-09-20
05060500090500Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2016-09-20
00628063400270CALCIUMSEKISUI DIAGNOSTICS, LLCCJY2016-09-20
00851445007099GENCHEM™Calcium, Azo Dye ReagentGENCHEM INCCJY2016-09-19
05055273200881Calcium (Ca)RANDOX LABORATORIES LIMITEDCJY2016-09-16
05055273200904CaRANDOX LABORATORIES LIMITEDCJY2016-09-16