Thermo Scientific

GUDID 00845275002591

Fisher Diagnostics

Total lactate dehydrogenase (LDH) IVD, reagent

• Primary Device ID: 00845275002591
• NIH Device Record Key: 8d25e34c-dfca-4c71-bb72-8b04c3a23909
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Scientific
• Version Model Number: TR20015
• Company DUNS: 183998769
• Company Name: Fisher Diagnostics
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-528-0494
• Email: xx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845275002591 [Primary]
GS1	00845275006179 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860728

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Thermo Scientific ]

• 00845275003772: TS3000
• 00845275002997: TR34026
• 00845275002973: TR33321
• 00845275002591: TR20015
• 00845275002348: TR14314
• 00845275002300: TR14010
• 00845275001068: 1245250
• 00845275000412: TR11320
• 00845275000405: TR36026