Immco Diagnostics, Inc 5170

GUDID 00845714004827

Enhanced Anti-RNA POL lll Antibody ELISA

IMMCO DIAGNOSTICS, INC.

RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845714004827
• NIH Device Record Key: cedb7954-28c9-46f3-aa28-4fc7ddcd55d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immco Diagnostics, Inc
• Version Model Number: 5170
• Catalog Number: 5170
• Company DUNS: 079935300
• Company Name: IMMCO DIAGNOSTICS, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com
• Phone: 1-800-537-8378
• Email: info@immco.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845714004827 [Primary]

FDA Product Code

• NYO: Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

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: 2018-08-03
• Device Publish Date: 2018-07-03

On-Brand Devices [Immco Diagnostics, Inc]

• 00845714004827: Enhanced Anti-RNA POL lll Antibody ELISA
• 00845714002427: B2GP1 IgA ELISA
• 00845714002045: ImmuGlo HEp-2 ELITE IFA