HEMO BIOSCIENCE

FDA Device Registration & Listing · Durham, NC, US · Registration 3017237798

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017237798
FEI Number
3017237798
Entity Name
HEMO BIOSCIENCE
City/State/Country
Durham, NC, US
Establishment Address
4022 stirrup creek dr, suite 311, Durham, NC 27703, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hemo bioscience (Owner Number: 10090845)
Owner / Operator Contact Address
4022 stirrup creek dr, suite 311, Durham, NC 27703, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hemo QC Validation and Competency Kit MQC-CAT Anti-A1 Lectin 0.2M DTT MQC ELUCLEAR ACID ELUTION KIT C3 Control Cells HBS-Lectin Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2024-05-21
DGR Whole Human Serum, Antigen, Antiserum, Control Immunology Class 1 866.5700 2024-05-21
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2024-05-21
KSX Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use Hematology Class 2 864.9160 2024-05-21
KSK Solution, Stabilized Enzyme Hematology Class 2 864.9400 2024-05-21
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2024-05-21
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2024-05-21
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2024-05-21
KSI Lectins And Protectins Hematology Class 2 864.9550 2024-10-31

Official Correspondent

noel brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hemo bioscience
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017237798. Last updated year: 2026. Please use registration number 3017237798 when referencing this establishment in official correspondence.
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