Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent 0066430

GUDID 10888234002239

Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the detection of the Fya (FY1) antigen on red blood cells with the indirect antiglobulin test by tube and microplate technique. Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is prepared from IgG antibodies from the human/murine heterohybridoma cell line P3TIM grown in fluid culture and suitably diluted in a proprietary diluent containing bovine albumin to achieve the appropriate level of potency for the test procedure as described. Sodium azide is added as a preservative (at less than 0.1% w/v). Ready for use as supplied.

IMMUCOR, INC.

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

• Primary Device ID: 10888234002239
• NIH Device Record Key: e299d34b-edac-4c33-b45c-ff3cc076dba4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent
• Version Model Number: 10 mL size vial / 5mL fill volume
• Catalog Number: 0066430
• Company DUNS: 061446282
• Company Name: IMMUCOR, INC.
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234002239 [Primary]

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: 2022-05-02
• Device Publish Date: 2022-04-22

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