Immco Diagnostics, Inc 5152A

GUDID 00845714002427

B2GP1 IgA ELISA

IMMCO DIAGNOSTICS, INC.

Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845714002427
• NIH Device Record Key: a83276c5-a779-4676-b82e-22d1d6d955b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immco Diagnostics, Inc
• Version Model Number: 5152A
• Catalog Number: 5152A
• 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	00845714002427 [Primary]

FDA Product Code

• MSV: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

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: 2017-07-11

On-Brand Devices [Immco Diagnostics, Inc]

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