Coombs Control Cells 213630

GUDID 07640137340599

For use in quality control of anti-human globulin procedures. For in vitro diagnostic use.

Medion Grifols Diagnostics AG

Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control Multiple immunohaematology test IVD, control

• Primary Device ID: 07640137340599
• NIH Device Record Key: cd7c112d-ed3c-4d72-b2da-682bc16a5a30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coombs Control Cells
• Version Model Number: 1 x 10 ml
• Catalog Number: 213630
• Company DUNS: 483287020
• Company Name: Medion Grifols Diagnostics AG
• 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: true
• 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	07640137340599 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

Devices Manufactured by Medion Grifols Diagnostics AG

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• 07640137341459 - Data-Cyte Plus 2 0.8%: 2024-04-30 Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use.
• 07640137341749 - Data-Cyte Plus 3%: 2024-04-18 Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.
• 07640137341596 - Search-Cyte Pool 0.8%: 2024-04-17 Reagent Red Blood Cells for use in the detection of unexpected antibodies in gel technique. For in vitro diagnostic use
• 07640137341381 - DG Gel Essential Control: 2019-05-01 DG Gel Essential Control is intended to allow regular quality control of materials, work procedures and instrument procedures fo
• 07640137340278 - Data-Cyte Plus 3%: 2018-03-29 Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.
• 07640137340285 - Data-Cyte Plus 0.8%: 2018-03-29 Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnotic use.
• 07640137340292 - Reverse-Cyte 3% (A1, B): 2018-03-29 Reagent Red Blood Cells for confirmation of ABO Blood Grouping. For in vitro diagnostic use.