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AGILENT TECHNOLOGIES SINGAPORE PTE LTD

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?

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: —
Email: [email protected]
Phone: +4544859500
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 894671143

Catalogue (557)

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Device	Model / Reference	Registries	Class	Status
Mono Mo A-Hu CD56 Cl 123C3	M7304	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Cytokeratin 18 Cl DC 10 RTU (Link)	IR618	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu Calcitonin RTU (Dako Omnis)	GA515	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu Gastrin RTU	IS519	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD8 Cl C8/144B RTU (Dako Omnis)	GA623	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD20cy Cl L26 RTU	IS604	FDA UDI	Class I	Active
Poly Rb A-Hu Calcitonin	A0576	FDA UDI	Class I	Unknown
FLEX Mono Mo A-Hu CD246, ALK Protein Cl ALK1 RTU (Dako Omnis)	GA641	FDA UDI	Class I	Active
Mono Mo A-Hu CD4 Cl 4B12	M7310	FDA UDI	Class I	Active
Poly Rb a Hu Kappa LC/FITC + Poly Rb a Hu Lambda LC/RPE	FR481	FDA UDI	Class I	Active
Mono Mo A-Hu CD7/PerCP-Cy5.5 Cl CBC.37	PR711	FDA UDI	Class I	Active
Mono Mo A-Hu Thyroglobulin Cl DAK-Tg6	M0781	FDA UDI	Class I	Active
Mono Mo A-Hu B-Cell-Specific Activator Protein Cl DAK-Pax5	M7307	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7 RTU (Link)	IR622	FDA UDI	Class I	Active
HercepTest™ for the Dako Autostainer	K5207	FDA UDI	Class III	Unknown
FLEX Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 RTU	IS637	FDA UDI	Class I	Active
Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/FITC	F0200	FDA UDI	Class II	Active
Dako Omnis DIW Tank	GC125	EUDAMEDFDA UDI	Class I	Active
Ig Reagent Rb F(ab')2/FITC	X0929	FDA UDI	Class I	Active
Mono Mo A-Hu CD235a, Glycophorin A Cl JC159	M0819	FDA UDI	Class I	Active
Mono Mo A-Hu Desmin Cl D33	M0760	FDA UDI	Class I	Active
Monoclonal Mouse Anti- Cytomegalovirus Clones CCH2 + DDG9	M0854	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Ki-67 Antigen Cl MIB-1 RTU (Link)	IR626	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD4 Cl 4B12 RTU	IS649	FDA UDI	Class I	Active
Mono Mo A-Hu BCL2 Oncoprotein Cl 124	M0887	FDA UDI	Class I	Active
Mono Mo A-Hu CD45, Leucocyte Common Antigen/APC Cl T29/33	C7230	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Epithelial Membrane Antigen Cl E29 RTU	IS629	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Muscle Actin Cl HHF35 RTU	IS700	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Cytokeratin 7 Cl OV-TL 12/30 RTU (Dako Omnis)	GA619	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu IgM, RTU (Dako Omnis)	GA513	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD20cy Cl L26 RTU (Dako Omnis)	GA604	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu Kappa LC RTU (Link)	IR506	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Cytokeratin 18 Cl DC 10 RTU (Dako Omnis)	GA618	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD57, Cl TB01, RTU (Dako Omnis)	GA647	FDA UDI	Class I	Active
Mono Mo a Hu CD117, c-kit/RPE, Cl 104D2	R7145	FDA UDI	Class I	Active
Poly Rb a Hu Lambda LC/RPE, Rb F(ab')2	R0437	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu Von Willebrand Factor RTU (Dako Omnis)	GA527	FDA UDI	Class I	Active
Mono Mo A-Hu Cytokeratin 5/6 Cl D5/16 B4	M7237	FDA UDI	Class I	Active
Mono Mo A-Hu CD5/FITC Cl DK23	F0795	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7 RTU	IS622	FDA UDI	Class I	Active
Poly Rb A-Hu IgA/HRP	P0216	FDA UDI	Class II	Active
FLEX Mono Mo A-Hu Smooth Muscle Actin Cl 1A4 RTU	IS611	FDA UDI	Class I	Active
Mono Mo A-Hu Prostate-Specific Antigen Cl ER-PR8	M0750	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CA 125 Cl M11 RTU (Dako Omnis)	GA701	FDA UDI	Class I	Active
Mono Mo a Hu CD117, c-kit/APC Cl 104D2	C7244	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Cytokeratin 20 Cl Ks20.8 RTU (Dako Omnis)	GA777	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Hepatocyte Cl OCH1E5 RTU (Dako Omnis)	GA624	FDA UDI	Class I	Active
Mono Mo a Hu CD7/RPE, Cl CBC.37	R7277	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Cytokeratin 7 Cl OV-TL 12/30 RTU	IS619	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Smooth Muscle Actin, Cl 1A4, RTU (Dako Omnis)	GA611	FDA UDI	Class I	Active

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