iqproducts.nlAnti-HbF R-PE - The R-PE conjugated monoclonal antibody anti-Hemoglobin F (HbF), clone NaM16-2F4, reacts with the y-chain of the human fetal hemoglobin molecule in its intact form.
2024-11-13
IQ PRODUCTS B.V.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9681582 | 3002807541 | IQ PRODUCTS B.V. | 1 | N | 2026-01-01 | ROZENBURGLAAN 13A GRONINGEN NL 9727DL |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08719327450949 | Anti-HbF PURE - The purified monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form. | +31505757000 | orders@iqproducts.nl |
| 08719327450956 | Anti-HbF FITC - The FITC conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form. | +31505757000 | orders@iqproducts.nl |
| 08719327450963 | Anti-HbF R-PE - The R-PE conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form. | +31505757000 | orders@iqproducts.nl |
| 08719327450970 | Anti-HbF Dy-410 - The Dy-410 conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form. | +31505757000 | orders@iqproducts.nl |
| 08719327450987 | anti-HbS PURE - The purified monoclonal antibody anti-Hemoglobin S (HbS) recognizes the B-chain of the human hemoglobin. | +31505757000 | orders@iqproducts.nl |
| 08719327450994 | anti-HbS FITC - The FITC conjugated monoclonal antibody anti-Hemoglobin S (HbS) recognizes the B-chain of the human hemoglobin. | +31505757000 | orders@iqproducts.nl |
| 08721264790002 | Anti-HbF R-PE - The R-PE conjugated monoclonal antibody anti-Hemoglobin F (HbF), clone NaM16-2F4, reacts with the y-chain of the human fetal hemoglobin molecule in its intact form. | +31505757000 | orders@iqproducts.nl |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 52104 | 1232224994 | K991650 | CMV BRITE TURBO KIT | LIN | 1999-07-12 |
| 52104 | 1816575870 | K951550 | CMV BRITE ANTIGENEMIA TEST KIT | LIN | 1996-01-30 |
| 52104 | 1604307485 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LIN | 2 | 1999-07-12 |
GUDID#
Anti-panHb APC - The APC conjugated monoclonal antibody anti-pan Hemoglobin (panHb) antibody recognizes the α-chain of human hemoglobin.
2023-07-19
Anti-HbF PURE - The purified monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form.
2023-01-26
Anti-HbF FITC - The FITC conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form.
2023-01-26
Anti-HbF R-PE - The R-PE conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form.
2023-01-26
Anti-HbF Dy-410 - The Dy-410 conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form.
2023-01-26
anti-HbS PURE - The purified monoclonal antibody anti-Hemoglobin S (HbS) recognizes the B-chain of the human hemoglobin.
2023-01-26
anti-HbS FITC - The FITC conjugated monoclonal antibody anti-Hemoglobin S (HbS) recognizes the B-chain of the human hemoglobin.
2023-01-26
CD163 PURE - The purified monoclonal antibody CD163 (clone MAC2-158) detects human CD163. It targets an epitope within the SRCR1 domain from the N-terminal region.
2023-01-26
CD163 FITC - The FITC conjugated monoclonal antibody CD163 (clone MAC2-158) detects human CD163. It targets an epitope within the SRCR1 domain from the N-terminal region.
2023-01-26
CD163 R-PE - The R-PE conjugated monoclonal antibody CD163 (clone MAC2-158) detects human CD163. It targets an epitope within the SRCR1 domain from the N-terminal region.
2023-01-26
CD163 Biotin - The Biotin conjugated monoclonal antibody CD163 (clone MAC2-158) detects human CD163. It targets an epitope within the SRCR1 domain from the N-terminal region.
2023-01-26
CD64 PURE - The purified monoclonal antibody CD64 (clone 22) binds to 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 presenceof 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.
2023-01-26
CD64 CyQ - The CyQ conjugated monoclonal antibody CD64 (clone 22) binds to 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.
2023-01-26
CD64 FITC - The FITC conjugated monoclonal antibody CD64 (clone 22) binds to 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.
2023-01-26
CD64 R-PE - The R-PE conjugated monoclonal antibody CD64 (clone 22) binds to 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.
2023-01-26
CD64 R-PE - 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.
2023-01-26
CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit - The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
2016-09-19
CMV Brite™, CMV antigenemia detection kit - The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
2016-09-19
CMV Brite™ Turbo, CMV antigenemia detection kit - The CMV Brite™ Turbo Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence in isolated peripheral blood leukocytes obtained from EDTA and heparin anticoagulated human peripheral blood. The detection of CMV pp65 in human leukocytes aids in the diagnosis of acute or reactivated CMV infection.
2016-09-19
CMV Brite™ Turbo Control Slides - CMV Brite™ Turbo Control Slides are a component of the CMV Brite™ Turbo kit which can be used as a control in the fluorescence staining of this kit. Slides with a positive and negative side are provided in a sealed pouch with desiccant and are ready to use. Positive side contains pp65 positive sf9 cells. Cells are fixated. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
2016-09-19
Reagent A - CMV Brite™ Turbo kit - Reagent A is a component of the CMV Brite™ Turbo kit which can be used in direct lysis of peripheral blood erythrocytes. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
2016-09-19
Reagent B - CMV Brite™ Turbo kit - Reagent B is a component of the CMV Brite™ Turbo kit which can be used as a fixative peripheral blood leukocytes on slides. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
2016-09-19
Reagent C - CMV Brite™ Turbo kit - Reagent C is a component of the CMV Brite™ Turbo kit which can be used as a permeabilization solution for peripheral blood leukocytes on slides. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
2016-09-19
Reagent D - CMV Brite™ Turbo kit - Reagent D is a component of the CMV Brite™ Turbo kit which can be used in immunofluorescence staining. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
2016-09-19
Reagent E - CMV Brite™ Turbo kit - Reagent E is a component of the CMV Brite™ Turbo kit which can be used in immunofluorescence staining. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
2016-09-19