DG Therm 213734

GUDID 08437014205169

DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.

DIAGNOSTIC GRIFOLS SA

Microplate/tube/assay card incubator IVD

• Primary Device ID: 08437014205169
• NIH Device Record Key: 23b51e9f-41a3-4307-8b3a-9183d60a6be5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG Therm
• Version Model Number: 213734
• Catalog Number: 213734
• Company DUNS: 463625602
• Company Name: DIAGNOSTIC GRIFOLS SA
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK120046

FDA Product Code

• PBC: Manual Blood Grouping And Antibody Test Systems

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: 2025-04-29
• Device Publish Date: 2016-09-06

Devices Manufactured by DIAGNOSTIC GRIFOLS SA

• 08437014205152 - DG Spin: 2025-04-29 DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards.
• 08437014205169 - DG Therm: 2025-04-29DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
• 08437014205169 - DG Therm: 2025-04-29 DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology
• 08437014205008 - DG Gel 8 Neutral: 2025-04-22 The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use a
• 08437014205084 - DG Gel 8 Anti-K: 2025-04-16 The DG Gel 8 Anti-K card is for the determination of K antigen on the surface of red blood cells in eight human blood samples. F
• 08437014205091 - DG Gel 8 Anti-D: 2025-04-16 The DG Gel 8 Anti-D card is for the determination of D antigen on the surface of red blood cells of eight human blood samples. F
• 08437014205107 - DG Gel 8 Anti-AB: 2025-04-16 The DG Gel 8 Anti-AB card is for the determination of human A and B antigens on the surface of red blood cells of eight human bl
• 08437014205121 - DG Gel 8 Anti-E: 2025-04-16 For the determination of human E antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
• 08437014205138 - DG Gel 8 Anti-c: 2025-04-16 For the determination of human c antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel