Hemo-QC H9200

GUDID 00858352006009

Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.

HEMO BIOSCIENCE INC

Multiple blood group genotyping IVD, control

• Primary Device ID: 00858352006009
• NIH Device Record Key: 72b83b54-52d3-4141-a154-14c48d92c92d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemo-QC
• Version Model Number: H9200
• Catalog Number: H9200
• Company DUNS: 143647035
• Company Name: HEMO BIOSCIENCE 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: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com
• Phone: 1-866-332-2835
• Email: info@hemobioscience.com

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
• 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	00858352006009 [Primary]

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents

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: 2016-10-20

Devices Manufactured by HEMO BIOSCIENCE INC

• 00858352006009 - Hemo-QC: 2018-03-29Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
• 00858352006009 - Hemo-QC: 2018-03-29 Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, sem
• 00858352006016 - C3 Control Cells: 2018-03-29 C3 Control Cells are used to confirm the reactivity of anti-C3 in Anti-human globulin.
• 00858352006023 - ELUclear: 2018-03-29 ELUclear elution kit is used to elute antibodies from intact red blood cells.
• 00858352006122 - MQC: 2018-03-29 MQC is intended for the quality control of routine blood bank reagents when tested by tube technique.
• 00858352006139 - MQC-CAT: 2018-03-29 MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques.