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AGILENT TECHNOLOGIES SINGAPORE PTE LTD

US

Last updated May 24, 2026

What AGILENT TECHNOLOGIES SINGAPORE PTE LTD makes

Agilent Technologies Singapore Pte Ltd manufactures in vitro diagnostic (IVD) antibodies and related reagents, including cytokeratin IVD antibodies, kappa/lambda light chain immunoglobulin IVD antibodies, and various cell marker IVD antibodies such as CD3, CD4, CD8, CD34, CD45, and CD68. The company also produces microscope slide stainers IVD and associated accessories like Dako Omnis DI Water Filling Accessories for use in laboratory testing.

The manufacturer's devices are classified as Class I, Class II, and Class III medical devices and are listed in the FDA's Unique Device Identification (FDA UDI) system. Agilent Technologies Singapore Pte Ltd is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Agilent Technologies Singapore Pte Ltd manufacture?

Agilent Technologies Singapore Pte Ltd manufactures in vitro diagnostic (IVD) antibodies and related reagents, including cytokeratin IVD antibodies, kappa/lambda light chain immunoglobulin IVD antibodies, and various cell marker IVD antibodies such as CD3, CD4, CD8, CD34, CD45, and CD68. The company also produces microscope slide stainers IVD and associated accessories like Dako Omnis DI Water Filling Accessories for use in laboratory testing.

Where is Agilent Technologies Singapore Pte Ltd based?

Agilent Technologies Singapore Pte Ltd is based in the United States. The company operates from its headquarters in the US, where it develops and manufactures its diagnostic products and laboratory equipment.

Which regulatory registries list Agilent Technologies Singapore Pte Ltd's devices?

Agilent Technologies Singapore Pte Ltd's devices are listed in the FDA's Unique Device Identification (FDA UDI) system. This registry provides information about medical devices, including their identification, manufacturing details, and classification status.

How are Agilent Technologies Singapore Pte Ltd's devices classified?

Agilent Technologies Singapore Pte Ltd's devices are classified as Class I, Class II, and Class III medical devices. Class I devices pose the lowest risk, Class II devices require more regulatory controls, and Class III devices support or sustain human life and may present potential unreasonable risk of illness or injury.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
agilent.com
LinkedIn
—
Facebook
—
Phone
+4544859500
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
894671143

Catalogue (557)

Page 11 of 12
DeviceModel / ReferenceRegistriesClassStatus
Mono Mo A-Hu CD3/RPE, Cl UCHT1 R0810
FDA UDI
Class IIActive
Dako Omnis Waste Tank (NHz) GC126
FDA UDI
Class IActive
Mono Mo a Hu CD42b, Platelet Glycoprotein Ib/RPE, Cl AN51 R7014
FDA UDI
Class IActive
Mono Mo A-Hu BCL2 Oncoprotein Cl 124 M0887
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD7 Cl CBC.37 RTU IS643
FDA UDI
Class IActive
Mono Mo A-Hu CD7/FITC Cl DK24 F0789
FDA UDI
Class IActive
FLEX Poly Rb A-Hu IgG RTU (Link) IR512
FDA UDI
Class IActive
Mono Mo AHu CD43/FITC Cl DF-T1 F7102
FDA UDI
Class IActive
Mono Mo A-Hu Glial Fibrillary Acidic Protein Cl 6F2 M0761
FDA UDI
Class IActive
Mono Mo a Hu CD13/RPE, Cl WM-47 R0715
FDA UDI
Class IActive
Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJ M0792
FDA UDI
Class IActive
FLEX Poly Rb A-Hu Chorionic Gonadotropin RTU IS508
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Cytokeratin 20 Cl Ks20.8 RTU IS777
FDA UDI
Class IActive
Negative Control Mo IgG2a X0943
FDA UDI
Class IActive
Mono Mo A-Hu CD20cy Cl L26 M0755
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Synaptophysin, Cl DAK-SYNAP, RTU (Dako Omnis) GA660
FDA UDI
Class IActive
FLEX Mono Mo A-Vimentin Cl V9 RTU (Link) IR630
FDA UDI
Class IActive
TO DISCONTINUE IN US: Isotype Reagent Mo IgG2b/FITC X0941
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD10, Cl DAK-CD10, RTU (Dako Omnis) GA786
EUDAMEDFDA UDI
Class IActive
HER2 CISH pharmDx™ Kit SK109
FDA UDI
Class IIIActive
HercepTest™ K5204
FDA UDI
Class IIIUnknown
Mono Mo A-Hu LAT Protein Cl LAT-1 M7279
FDA UDI
Class IActive
Mono Mo A-Hu p53 Protein Cl DO-7 M7001
FDA UDI
Class IActive
Mono Mo A-Hu CD235a, Glycophorin A/FITC Cl JC159 F0870
FDA UDI
Class IActive
Mono Mo A-Hu CD16, Fc Gamma Receptor III/FITC Cl DJ130c F7011
FDA UDI
Class IActive
Poly Rb A-Hu IgG/FITC Rb F(ab')2 F0315
FDA UDI
Class IActive
Mono Mo a Hu CD19/FITC + Poly Rb a Hu Lambda LC/RPE + Poly Rb a Hu Kappa LC/APC TC669
FDA UDI
Class IUnknown
Mono Mo A-Hu Von Willebrand Factor Cl F8/86 M0616
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Ki-67 Antigen Cl MIB-1 RTU IS626
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD19, Cl LE-CD19, RTU (Dako Omnis) GA656
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Synaptophysin Cl DAK-SYNAP RTU (Link) IR660
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD2 Cl AB75 RTU (Link) IR651
FDA UDI
Class IActive
FLEX Poly Rb A-Hu Thyroglobulin RTU IS509
FDA UDI
Class IActive
Poly Rb A-Hu Lysozyme EC 3.2.1.17 A0099
FDA UDI
Class IActive
Mono Mo a Hu CD23/RPE, Cl MHM6 R7108
FDA UDI
Class IActive
ISH Pepsin (Dako Omnis) GM302
FDA UDI
Class IActive
Dako Omnis Waste Tank (Hz) GC127
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD10 Cl 56C6 RTU (Dako Omnis) GA648
FDA UDI
Class IActive
Mono Mo A-Hu Cytokeratin 5/6 Cl D5/16 B4 M7237
FDA UDI
Class IActive
Poly Rb A-Hu IgA/FITC Rb F(ab')2 F0316
FDA UDI
Class IActive
Mono Mo A-Hu CD246, ALK Protein Cl ALK1 M7195
FDA UDI
Class IActive
Poly Rb A-Hu Thyroglobulin A0251
FDA UDI
Class IActive
Mono Mo A-Hu HLA-DP, DQ, DR Antigen Cl CR3/43 M0775
FDA UDI
Class IActive
Poly Rb A-Hu Albumin/FITC F0117
FDA UDI
Class IIActive
Mono Mo A-Hu Glycophorin C Cl Ret40f M0820
FDA UDI
Class IActive
Poly Rb A-Hu IgG/FITC Rb F(ab')2 F0185
FDA UDI
Class IActive
Mono Mo A-Hu CD64, Fc Gamma Receptor I/APC Cl 10.1 C7278
FDA UDI
Class IActive
Mono Mo A-Hu Epidermal Growth Factor Receptor Cl E30 M7239
FDA UDI
Class IActive
Mono Mo A-Hu CD14/FITC Cl TÜK4 F0844
FDA UDI
Class IActive
Mono Mo A-Hu Epithelial Membrane Antigen Cl E29 M0613
FDA UDI
Class IActive

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