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

• 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