FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448

Primary DI
00817302024326
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
CC448
Catalog number
CC448
Device description
CREATININE CHECK
Published
2022-08-19
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
CGXALKALINE PICRATE, COLORIMETRY, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGXAlkaline Picrate, Colorimetry, CreatinineClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302024326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302024326008173020243268173020243260817302024326

GMDN Terms#

Term, Definition table
TermDefinition
Urine creatinine IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for creatinine within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume500Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
Premarket exempt
true
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
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
00630414611075Atellica CH Crea3Siemens Healthcare Diagnostics Inc.CGX2026-05-08
00630414653259Atellica CH Crea3Siemens Healthcare Diagnostics Inc.CGX2026-05-08
10673486014037Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240TECO DIAGNOSTICSCGX2026-04-30
10673486014044Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480TECO DIAGNOSTICSCGX2026-04-30
00380740159528AlinityABBOTT IRELANDCGX2024-08-15
00380740159535ARCHITECTABBOTT IRELANDCGX2024-08-15
00850053916106IDG/SanzayIDG/SANZAY CorporationCGX2024-01-09
10673486001518Teco Diagnostics Creatinine (Kinetic or Manual Endpoint Method) Reagent SetTECO DIAGNOSTICSCGX2023-11-06
10673486001549Teco Diagnostics Creatinine (Kinetic) Reagent Kit TC-MATRIX-240/480TECO DIAGNOSTICSCGX2023-11-06
10673486001556Teco Diagnostics Creatinine Reagent Set (Direct Endpoint Procedure)TECO DIAGNOSTICSCGX2023-11-06
10673486001532Teco Diagnostics Creatinine (Kinetic) Reagent SetTECO DIAGNOSTICSCGX2023-10-26
00811403011117Creatinine ReagentDiamond Diagnostics Inc.CGX2023-06-05
00811727016119Pointe Creatinine ReagentHORIBA INSTRUMENTS INCORPORATEDCGX2021-01-30
00811727015808Pointe Creatinine for BS480HORIBA INSTRUMENTS INCORPORATEDCGX2020-05-28
03610230006955Yumizen C1200 Creatinine JafféHORIBA ABX SASCGX2020-05-06
00380740161552ARCHITECTAbbott GmbHCGX2020-03-21
00380740161569ARCHITECTAbbott GmbHCGX2020-03-21
07613336121177Creatinine Jaffe Gen.2Roche Diagnostics GmbHCGX2020-03-05
05055273201901CREATININE (CREA)RANDOX LABORATORIES LIMITEDCGX2019-06-03
00380740135119AlinityAbbott GmbHCGX2018-08-31
00380740135102AlinityAbbott GmbHCGX2018-08-08
00852169008126ClearChem Diagnostics Inc. Creatinine (Jaffe)CLEARCHEM DIAGNOSTICS INC.CGX2018-04-30
50885380153288MEDI-VACCardinal Health 200, LLCCGX2018-04-09
50885380153295MEDI-VACCardinal Health 200, LLCCGX2018-04-09
50885380153301MEDI-VACCardinal Health 200, LLCCGX2018-04-09
00630414596457Atellica CH Crea_2Siemens Healthcare Diagnostics Inc.CGX2017-12-21
05060500091873Synermed®INFRARED LABORATORY SYSTEMS LLCCGX2017-02-28
00812137011961Creatinine Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CGX2016-10-12
00817274022337JAS DiagnosticsDREW SCIENTIFIC, INC.CGX2016-10-11
15099590010737AUBeckman Coulter, Inc.CGX2016-09-24