Fasciola hepatica IgG ELISA 9650

GUDID 07640158219652

The Fasciola hepatica ELISA test is a qualitative enzyme immunoassay for the detection of Fasciola hepatica antibodies in human serum samples.

Bordier affinity products S.A.

Fasciola hepatica total antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07640158219652
• NIH Device Record Key: 8e182404-e296-45f1-8202-d58dc442ecbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fasciola hepatica IgG ELISA
• Version Model Number: 9650
• Catalog Number: 9650
• Company DUNS: 487811143
• Company Name: Bordier affinity products S.A.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41216333167
• Email: cb@bordier.ch

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640158219652 [Primary]

FDA Product Code

• KHW: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

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: 2022-10-10
• Device Publish Date: 2022-09-30

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