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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 7 of 12
DeviceModel / ReferenceRegistriesClassStatus
HER2 IQFISH pharmDx™ K5731
FDA UDI
Class IIIActive
Mono Mo A-Hu MUC5AC Cl CLH2 M7316
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD20cy Cl L26 RTU (Link) IR604
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD34 Class II Cl QBEnd 10 RTU IS632
FDA UDI
Class IActive
Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 M0804
FDA UDI
Class IActive
Mono Mo a Hu CD41, Platelet Glycoprotein IIb/RPE, Cl 5B12 R7058
FDA UDI
Class IActive
FLEX Mono Mo A-Cytokeratin 17 Cl E3 RTU (Link) IR620
FDA UDI
Class IActive
FLEX Poly Rb A-Hu IgG RTU IS512
FDA UDI
Class IActive
Dako X0974
FDA UDI
Class IActive
Mono Mo A-Hu MUC2 Cl CCP58 M7313
FDA UDI
Class IActive
Poly Rb A-Hu Kappa LC/APC Rb F(ab')2 C0222
FDA UDI
Class IActive
Mono Mo A-Hu Amyloid A Cl mc1 M0759
FDA UDI
Class IActive
Mono Mo A-Hu Smooth Muscle Actin Cl 1A4 M0851
FDA UDI
Class IActive
MultiMix Dual-Colour Reagent A-Hu CD4/FITC, A-Hu CD8/RPE FR868
FDA UDI
Class IIActive
FLEX Poly Rb A-Glial Fibrillary Acidic Protein RTU (Dako Omnis) GA524
FDA UDI
Class IActive
Mono Mo A-Hu CD34 Class III/APC Cl BIRMA-K3 C7238
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD7 Cl CBC.37 RTU (Dako Omnis) GA643
FDA UDI
Class IActive
Mono Mo A-Hu CD68 Cl EBM11 M0718
FDA UDI
Class IActive
Poly Rb A-Hu IgG A0423
FDA UDI
Class IActive
Mono Mo A-Hu Epithelial Membrane Antigen Cl E29 M0613
FDA UDI
Class IActive
Mono Mo A-Hu Myeloperoxidase/APC, Cl MPO-7 C7246
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD246, ALK Protein Cl ALK1 RTU (Link) IR641
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD43 Cl DF-T1 RTU (Dako Omnis) GA636
FDA UDI
Class IActive
Mono Mo A-Hu CD45R0 Cl UCHL1 M0742
FDA UDI
Class IActive
Poly Rb A-Hu Kappa Free LC A0100
FDA UDI
Class IIActive
Poly Rb a Hu IgM/RPE, Rb F(ab')2 R5111
FDA UDI
Class IActive
FLEX Mono Mo A-Hu ZAP-70 Cl 2F3.2 RTU (Link) IR653
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Neurofilament Protein Cl 2F11 RTU (Link) IR607
FDA UDI
Class IActive
Beckman Coulter Beta-2-Microglobulin Kit A09445
FDA UDI
Class IIActive
FLEX Mono Mo A-Hu CD10 Cl 56C6 RTU (Link) IR648
FDA UDI
Class IActive
MultiMix Dual-Colour Reagent A-Hu CD3/FITC A-Hu CD19/RPE FR866
FDA UDI
Class IIActive
FLEX Poly Rb A-Hu Gastrin RTU (Link) IR519
FDA UDI
Class IActive
Mono Mo a Hu CD79acy/RPE, Cl HM57 R7159
FDA UDI
Class IActive
Mono Mo A-Hu CD30/FITC Cl Ber-H2 F0849
FDA UDI
Class IActive
Isotype Reagent Mo IgG2a/FITC X0933
FDA UDI
Class IActive
Mono Mo A-Hu Smooth Muscle Actin Cl 1A4 M0851
FDA UDI
Class IActive
Ig Reagent Rb F(ab')2/RPE X0930
FDA UDI
Class IActive
Mono Mo A-Hu CD4/APC Cl MT310 C7226
FDA UDI
Class IActive
Mono Mo A-Hu CD22/PerCP-Cy5.5 Cl 4KB128 PR707
FDA UDI
Class IActive
Control Reagent Mo IgG1/FITC + Rb F(ab')2/RPE + Rb F(ab')2/APC X0979
FDA UDI
Class IActive
Poly Rb A-Hu IgA A0262
FDA UDI
Class IIActive
Mono Mo a Hu CD33/RPE, Cl WM-54 R0745
FDA UDI
Class IActive
Mono Mo A-Hu MUM1 Protein Cl MUM1p M7259
FDA UDI
Class IActive
FLEX Poly Rb A-Hu CD3 RTU (Dako Omnis) GA503
FDA UDI
Class IActive
FLEX Mono Rb a Hu PMS2, Cl EP51 RTU (Dako Omnis) GA087
EUDAMEDFDA UDI
Class IActive
Poly Rb A-Hu Lambda LC/FITC F0199
FDA UDI
Class IIActive
Mono Mo A-Hu CD4 Cl 4B12 M7310
FDA UDI
Class IActive
Mono Mo A-Hu CD19/FITC Cl HD37 F0768
FDA UDI
Class IActive
Mono Mo A-Hu CD23/FITC Cl MHM6 F7062
FDA UDI
Class IActive
Poly Rb A-Hu Kappa LC/FITC Rb F(ab')2 F0434
FDA UDI
Class IActive

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