Fisher Labcorp ES Take Home Pack 80

GUDID 00613647001066

FISHER SCIENTIFIC COMPANY L.L.C.

Faecal occult blood IVD, kit, chromogenic, rapid

• Primary Device ID: 00613647001066
• NIH Device Record Key: e6159f04-07d0-4e35-8e0f-9ff8b729d0df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fisher Labcorp ES Take Home Pack 80
• Version Model Number: 551790
• Company DUNS: 004321519
• Company Name: FISHER SCIENTIFIC COMPANY L.L.C.
• 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: 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613647001066 [Primary]

FDA Product Code

• KHE: REAGENT, OCCULT BLOOD

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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