hemochroma PLUS Optical System Check 100-404

GUDID 10722355003044

hemochroma PLUS Optical System Check is intended to assure the performance of the optic system of the hemochroma PLUS Analyzer.

Immunostics Company, Inc

Total haemoglobin (totHb) IVD, control

• Primary Device ID: 10722355003044
• NIH Device Record Key: 6f069f11-af00-4221-a62c-fb47d9425410
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hemochroma PLUS Optical System Check
• Version Model Number: 100-404
• Catalog Number: 100-404
• Company DUNS: 119214195
• Company Name: Immunostics Company, 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: false
• 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(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com
• Phone: +1(732)918-0770
• Email: technical@immunostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10722355003044 [Primary]

FDA Product Code

• GKR: SYSTEM, HEMOGLOBIN, AUTOMATED

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: 2025-03-31
• Device Publish Date: 2018-12-20

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