FDA.reportPublic FDA data

Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set

Primary DI
10673486001648
Brand
Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set
Company
TECO DIAGNOSTICS
Model
C614-30
Catalog number
C614-30
Device description
Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set is intended to measure the activity of isoenzyme CK-MB in human serum.
Published
2023-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGSNad Reduction/Nadh Oxidation, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915709000CREATINE KINASE-MB (CK-MB) REAGENT SETTech Intl. Co.1992-01-27CGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600164810673486001648

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-463-1111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053916090IDG/SanzayIDG/SANZAY CorporationCGS2024-01-09
10673486001655Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent SetTECO DIAGNOSTICSCGS2023-11-17
10673486001495Teco Diagnostics Creatine Kinase (CK-NAC) Reagent SetTECO DIAGNOSTICSCGS2023-07-27
10673486001501Teco Diagnostics Creatine Kinase (CK-NAC) Reagent SetTECO DIAGNOSTICSCGS2023-07-27
10673486001594Teco Diagnostics Creatine Kinase (CK-NAC) Liquid ReagentTECO DIAGNOSTICSCGS2023-07-27
10673486001617Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent TC MatrixTECO DIAGNOSTICSCGS2023-07-27
00811727016096Pointe Creatine Kinase ReagentHORIBA INSTRUMENTS INCORPORATEDCGS2021-01-30
03610230006948Yumizen C1200 CK-NACHORIBA ABX SASCGS2020-08-31
00811727015785Pointe Creatine Kinase for BS480HORIBA INSTRUMENTS INCORPORATEDCGS2020-05-28
00380740161699ARCHITECTAbbott GmbHCGS2020-01-25
00380740161705ARCHITECTAbbott GmbHCGS2020-01-25
00380740132590AlinityAbbott GmbHCGS2019-05-07
00386100002183CK Reagent Kit MEDICA CORPORATIONCGS2019-02-14
00630414008943ADVIA Chemistry Creatine KinaseSiemens Healthcare Diagnostics Inc.CGS2018-11-12
00628063401079Creatine Kinase AssaySEKISUI DIAGNOSTICS, LLCCGS2018-09-24
00852169008089ClearChem Diagnostics Inc. Creatine Kinase (CK)CLEARCHEM DIAGNOSTICS INC.CGS2018-04-30
00630414006642Atellica CH CK_LSiemens Healthcare Diagnostics Inc.CGS2017-12-21
05060500091866Synermed®INFRARED LABORATORY SYSTEMS LLCCGS2017-02-28
00817302023039CAROLINA LIQUID CHEMISTRIES CORP.® CK REAGENT PRODUCT NO. DT207CAROLINA LIQUID CHEMISTRIES CORPORATIONCGS2016-10-17
00817302022940CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692CAROLINA LIQUID CHEMISTRIES CORPORATIONCGS2016-10-12
00812137011954CK-NAC Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CGS2016-10-12
15099590010744AUBeckman Coulter, Inc.CGS2016-09-24
15099590020262AUBeckman Coulter, Inc.CGS2016-09-24
00842768025556Dimension® Flex® reagent cartridge MBISiemens Healthcare Diagnostics Inc.CGS2016-09-24
00842768027925Dimension Vista® Flex® reagent cartridge CKISiemens Healthcare Diagnostics Inc.CGS2016-09-24
00857969006075ACEALFA WASSERMANN, INC.CGS2016-09-24
00857969006143ACEALFA WASSERMANN, INC.CGS2016-09-24
00630414209746ADVIA® Chemistry CKNAC Creatine Kinase ReagentsSiemens Healthcare Diagnostics Inc.CGS2016-09-24
00630414508337ADVIA® Chemistry CKNAC Creatine Kinase ReagentsSiemens Healthcare Diagnostics Inc.CGS2016-09-24
00015482771027SPOTCHEM™ II Uric AcidARKRAY USA, INC.CGS2016-09-23