DG Gel 8 Anti-IgG (Rabbit) 210394

GUDID 08437014205060

The DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.

DIAGNOSTIC GRIFOLS SA

Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

• Primary Device ID: 08437014205060
• NIH Device Record Key: d25e31d7-9bdf-496e-9b4a-c8df2a715919
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG Gel 8 Anti-IgG (Rabbit)
• Version Model Number: 210394
• Catalog Number: 210394
• 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
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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: 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
• 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
• 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
• Phone: (800)452-6877
• Email: service.americas@grifols.com
• Phone: (800)452-6877
• Email: service.americas@grifols.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205060 [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: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2015-07-22

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