Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set C512-60

GUDID 10673486001495

Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set is used for the quantitative determination of creatine kinase in human serum.

TECO DIAGNOSTICS

Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent Total creatine kinase (CK) IVD, reagent

• Primary Device ID: 10673486001495
• NIH Device Record Key: 30ba1fd7-1e72-4bd6-90be-3367bdd03a21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set
• Version Model Number: C512-60
• Catalog Number: C512-60
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486001495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864744

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: 2023-08-04
• Device Publish Date: 2023-07-27

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

• 10673486001501: Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set is used for the quantitative determination
• 10673486001495: Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set is used for the quantitative determination