Identity
- Trade Name
- CD64 R-PE FDA UDI
- Generic Name
- CD64 cell marker IVD, antibody FDA UDI
- Device Name
- The R-PE conjugated monoclonal antibody CD64 (clone 32.2) binds a CD64 epitope distinct from the ligand-binding site and from the clone 32.2 antibody to CD64 epitope. It shows especially high affinity binding to human mononuclear phagocytes and polymorphonuclear leukocytes exposed to IFN-y or G-CSF. Its binding is not blocked in the presence of human IgG or immune complexes. CD64 reacts with the Fc gamma receptor 1 (FcyR1), a glycoprotein with a molecular weight of 72 kDa. The antigen is a high-affinity receptor for IgG and is able to bind human IgG1 and IgG3. The antigen is expressed on macrophages, monocytes, and interferon y (IFN-y) and Granulocyte Colony Stimulating Factor (G-CSF) stimulated neutrophils. FDA UDI
- Model / Reference
- IQP-569R FDA UDI
- Description
- The R-PE conjugated monoclonal antibody CD64 (clone 32.2) binds a CD64 epitope distinct from the ligand-binding site and from the clone 32.2 antibody to CD64 epitope. It shows especially high affinity binding to human mononuclear phagocytes and polymorphonuclear leukocytes exposed to IFN-y or G-CSF. Its binding is not blocked in the presence of human IgG or immune complexes. CD64 reacts with the Fc gamma receptor 1 (FcyR1), a glycoprotein with a molecular weight of 72 kDa. The antigen is a high-affinity receptor for IgG and is able to bind human IgG1 and IgG3. The antigen is expressed on macrophages, monocytes, and interferon y (IFN-y) and Granulocyte Colony Stimulating Factor (G-CSF) stimulated neutrophils. FDA UDI
Identifiers
- Catalog Number
- IQP-569R FDA UDI
- Primary DI / UDI-DI
- 08719327451090 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- CD64 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CD64 cell marker IVD, antibody
Cd64 R-Pe by IQ Products B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD64 cell marker IVD, antibody.
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- Mono Mo a Hu CD64, Fc Gamma Receptor I/RPE, Cl 10.1 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Human CD64 R-PE Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Human CD64 APC Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Human CD64 FITC Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- Human CD64 Pacific Blue™ Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IQ Products B.V.
Sources (1)
- FDA UDI 5cfe29f7-0042-41e8-83ab-a53463d18909 36 fields · synced Jun 6, 2026