FDA.reportPublic FDA data

Creatinine Jaffe Gen.2

Primary DI
07613336121177
Brand
Creatinine Jaffe Gen.2
Company
Roche Diagnostics GmbH
Model
08057532190
Catalog number
08057532190
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CGXALKALINE PICRATE, COLORIMETRY, CREATININE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951595000ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESRoche Diagnostic Systems, Inc.1995-09-08CGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121177076133361211777613336121177

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 Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

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
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