Immco Diagnostics, Inc. 5163G

GUDID 00845714002502

AMA-M2 IgG ELISA

IMMCO DIAGNOSTICS, INC.

Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845714002502
• NIH Device Record Key: ee3b4d82-736d-4ffe-9aed-5402db53bd97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immco Diagnostics, Inc.
• Version Model Number: 5163G
• Catalog Number: 5163G
• 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: true
• 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	00845714002502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163133

FDA Product Code

• DBM: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

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: 2018-07-06
• Device Publish Date: 2017-09-07

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