Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set C614-30

GUDID 10673486001648

Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set is intended to measure the activity of isoenzyme CK-MB in human serum.

TECO DIAGNOSTICS

Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent

• Primary Device ID: 10673486001648
• NIH Device Record Key: d0e7a1ff-1e4c-481a-95b4-8905351b0dbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set
• Version Model Number: C614-30
• Catalog Number: C614-30
• Company DUNS: 185067774
• Company Name: TECO DIAGNOSTICS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486001648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915709

FDA Product Code

• CGS: Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-27
• Device Publish Date: 2023-11-17

On-Brand Devices [Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set]

• 10673486001655: Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set is intended to measure the activity of i
• 10673486001648: Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set is intended to measure the activity of i