FDA.reportPublic FDA data

Creatinine LiquiColor®

Primary DI
00657498000779
Brand
Creatinine LiquiColor®
Company
STANBIO LABORATORY, L.P.
Model
0420-500
Catalog number
0420-500
Device description
Quantitative Kinetic Determination of Creatinine in Serum or Urine.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00657498000779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000779006574980007796574980007790657498000779

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00657498001950Procalcitonin LiquiColor2300-0602300-0602017-06-26
00657498000434Albumin LiquiColor®0285-5000285-5002016-09-23
00657498001516Sirrus® Albumin LiquiColor®S0285-750S0285-7502016-09-23
00657498000847Glycated Serum Protein (GSP) LiquiColor®2350-0622350-0622016-09-23
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18
00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
00657498000441Alkaline Phosphatase LiquiColor®2900-4302900-4302016-09-23
00657498000458Alkaline Phosphatase LiquiColor®2900-5002900-5002016-09-23
00657498000489a-Amylase LiquiColor®2970-4302970-4302016-09-23
00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
00657498000502AST/SGOT Liqui-UV®2920-5002920-5002016-09-23
00657498000519B-Hydroxybutyrate LiquiColor®2440-0582440-0582016-09-23

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
00817302024326CAROLINA LIQUID CHEMISTRIES CORP.® CREATININE CHECK REAGENT KIT CC448CAROLINA LIQUID CHEMISTRIES CORPORATIONCGX2022-08-19
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