ichroma™ CRP i-CHOMRA CRP-25

GUDID 08806679001520

Boditech Med Inc.

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

• Primary Device ID: 08806679001520
• NIH Device Record Key: b10eb49a-9629-4a61-a10f-b8a5b63114d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ichroma™ CRP
• Version Model Number: i-CHOMRA CRP-25
• Catalog Number: i-CHOMRA CRP-25
• Company DUNS: 689062203
• Company Name: Boditech Med Inc.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com
• Phone: 732-9180770
• Email: ageffon@immunostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806679001520 [Primary]
GS1	18806679001527 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062981

FDA Product Code

• DCN: System, Test, C-Reactive Protein

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-17
• Device Publish Date: 2016-12-20

Devices Manufactured by Boditech Med Inc.

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• 08806133010099 - ichroma Reader: 2022-06-10
• 08806133010136 - ALFIS-3: 2021-12-14 FLUOROMETER FOR CLINICAL USE
• 08806133005262 - AFIAS TSH-SP: 2020-06-17 AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic
• 08806133005279 - AFIAS TSH-VB: 2020-06-17 AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro d
• 08806679001520 - ichroma™ CRP: 2020-06-17
• 08806679001520 - ichroma™ CRP: 2020-06-17
• 08806679002718 - ichroma™ iFOB: 2020-06-17