FDA.reportPublic FDA data

POINTE SCIENTIFIC CK-MB

Primary DI
00811727010940
Brand
POINTE SCIENTIFIC CK-MB
Company
HORIBA INSTRUMENTS INCORPORATED
Model
C7562-26
Catalog number
C7562-26
Device description
The CK-MB Reagent is for the quantitative determination of the isoenzyme Creatine Kinase-MB (CK-MB) in serum. For in vitro diagnostic use only.
Published
2016-08-31
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
JHWU.V. Method, Cpk Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHWU.V. Method, Cpk IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942958000CREATINE KINASE MB DETERMINATION (UV)Biochemical Trade, Inc.1994-11-21JHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727010940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727010940008117270109408117270109400811727010940

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen, using an enzyme spectrophotometry method.

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
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
052845583
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811727018977POINTE Chemistry Calibrator SetC7506-15C7506-152026-05-01
00811727015716Pointe ALT for the BS48014-A7526-37514-A7526-3752020-05-28
00811727015747Pointe BUN on BS48014-B7552-60014-B7552-6002020-05-28
00811727015761Pointe Creatinine Enzymatic on BS48014-C7548-21614-C7548-2162020-05-28
00811727015785Pointe Creatine Kinase for BS48014-C7522-22014-C7522-2202020-05-28
00811727015808Pointe Creatinine for BS48014-C7539-43214-C7539-4322020-05-28
00811727015822Pointe Direct Bilirubin for BS48014-HB936-20014-HB936-2002020-05-28
00811727015853Pointe HbA1c for the BS48014-H7546-16014-H7546-1602020-05-28
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727018632Pointe Scientific CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2021-02-28
00811727018649Pointe Scientific CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2021-02-28
00657498001547CK-MB Liqui-UV®STANBIO LABORATORY, L.P.JHW2016-10-11
00657498000748CK-MB TestSTANBIO LABORATORY, L.P.JHW2016-09-23
00817274021293JAS DiagnosticsDREW SCIENTIFIC, INC.JHW2016-09-09
00817274021309JAS DiagnosticsDREW SCIENTIFIC, INC.JHW2016-09-09
00817274021316JAS DiagnosticsDREW SCIENTIFIC, INC.JHW2016-09-09
00811727010957POINTE SCIENTIFIC CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2016-08-31
00811727010964POINTE SCIENTIFIC CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2016-08-31