DG Gel Extended Control 213285

GUDID 07640137340605

DG Gel Extended Control is intended to allow regular quality control of materials, work procedures and instrument procedures. For use with DG Gel 8 te

Medion Grifols Diagnostics AG

Multiple immunohaematology test IVD, control

• Primary Device ID: 07640137340605
• NIH Device Record Key: 62f2a89e-f184-49c0-9b0a-1a5a39a3665b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG Gel Extended Control
• Version Model Number: 4 x 6 ml
• Catalog Number: 213285
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640137340605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK140092

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

• 07640137341442 - Data-Cyte Extend 0.8%: 2024-04-30 Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. Data-Cyte Extend 0.8% cannot de
• 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.