Immco Diagnostics, Inc. 6101M-50

GUDID 00845714004810

Lyme B. burgdorferi (IgM) Marstripe Test

IMMCO DIAGNOSTICS, INC.

Multiple clinical chemistry protein IVD, kit, immunoblot

• Primary Device ID: 00845714004810
• NIH Device Record Key: 95594aeb-7dbc-4f85-b938-5bc0b5342ff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immco Diagnostics, Inc.
• Version Model Number: 6101M-50
• Catalog Number: 6101M-50
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845714004810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172254

FDA Product Code

• LSR: Reagent, Borrelia Serological Reagent

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: 2017-12-14

On-Brand Devices [Immco Diagnostics, Inc.]

• 00845714004841: Lyme B. burgdorferi (IgM) Marstripe Test
• 00845714004834: Lyme B. burgdorferi (IgM) Marstripe Test
• 00845714004810: Lyme B. burgdorferi (IgM) Marstripe Test
• 00845714004728: Lyme B. burgdorferi (IgG) Marstripe Test
• 00845714004711: Lyme B. burgdorferi (IgG) Marstripe Test
• 00845714004704: Lyme B. burgdorferi (IgG) Marstripe Test
• 00845714004117: HEp-2 cells / DFS-70 KO Slide
• 00845714003219: HeP-2 Cells Slide
• 00845714002670: ImmuLisa anti-gliadin IgA ELISA
• 00845714002663: ImmuLisa anti-gliadin IgG ELISA
• 00845714002526: AMA-M2 Screen ELISA
• 00845714002502: AMA-M2 IgG ELISA
• 00845714002458: B2GP1 Screen ELISA
• 00845714002441: B2GP1 IgM ELISA
• 00845714002434: B2GP1 IgG ELISA
• 00845714002069: ImmuGlo HEp-2 ELITE IFA
• 00845714002052: ImmuGlo HEp-2 ELITE IFA