Teco Diagnostics LDH-L Reagent Set L535-240

GUDID 10673486002072

Teco Diagnostics LDH-L Reagent Set is for the quantitative determination of lactate dehydrogenase activity in human serum.

TECO DIAGNOSTICS

Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent Total lactate dehydrogenase (LDH) IVD, reagent

• Primary Device ID: 10673486002072
• NIH Device Record Key: d2a11823-6a80-4989-ac13-12a349800a25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics LDH-L Reagent Set
• Version Model Number: L535-240
• Catalog Number: L535-240
• 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: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• 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	10673486002072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874848

FDA Product Code

• CFJ: Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

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: 2023-11-21
• Device Publish Date: 2023-11-13

On-Brand Devices [Teco Diagnostics LDH-L Reagent Set]

• 10673486002072: Teco Diagnostics LDH-L Reagent Set is for the quantitative determination of lactate dehydrogenas
• 10673486002065: Teco Diagnostics LDH-L Reagent Set is for the quantitative determination of lactate dehydrogenas