ORTHOTM Sera Anti-Fyb

GUDID 10758750013012

The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect antiglobulin test.

ALBA BIOSCIENCE LIMITED

Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody Anti-Fy^b red blood cell grouping IVD, antibody

• Primary Device ID: 10758750013012
• NIH Device Record Key: 0d8e844c-4222-4b6d-83a6-c8acb3b7c2ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOTM Sera Anti-Fyb
• Version Model Number: 6904547
• Company DUNS: 516536641
• Company Name: ALBA BIOSCIENCE LIMITED
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.com
• Phone: +41225458274
• Email: olivia.baud@quotientbd.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10758750013012 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-31
• Device Publish Date: 2017-06-21

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• 10758750013012 - ORTHOTM Sera Anti-Fyb: 2022-03-31 The Anti-Fyb reagent (Anti-FY2) is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect
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