CK-MB Test 0980-103

GUDID 00657498000748

For the Quantitative Determination of Creatine Kinase-MB (CK-MB) in Serum for Manual and/or Automated Procedures.

STANBIO LABORATORY, L.P.

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, enzyme spectrophotometry
Primary Device ID00657498000748
NIH Device Record Key2398aad5-e821-4319-a8c4-6ed9a6359449
Commercial Distribution StatusIn Commercial Distribution
Brand NameCK-MB Test
Version Model Number0980-103
Catalog Number0980-103
Company DUNS045361136
Company NameSTANBIO LABORATORY, L.P.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100657498000748 [Primary]

FDA Product Code

JHWU.V. Method, Cpk Isoenzymes

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

Devices Manufactured by STANBIO LABORATORY, L.P.

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00657498002339 - HGB Controls - Low2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498002346 - HGB Controls - Normal2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498002353 - HGB Controls - Normal2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498002360 - HGB Controls - High2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498002377 - HGB Controls - High2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498001806 - Standard 12020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy

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