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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)

Page 5 of 12

Device	Model / Reference	Registries	Class	Status
FLEX Mono Mo A-Hu CD79a Cl JCB117 RTU	IS621	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 RTU (Link)	IR637	FDA UDI	Class I	Active
Poly Rb A-Hu IgG/FITC	F0202	FDA UDI	Class II	Active
Mono Mo a Hu HLA-DR Antigen/RPE, Cl AB3	R7267	FDA UDI	Class I	Active
Mono Mo A-Hu Serotonin Cl 5HT-H209	M0758	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD57 Cl TB01 RTU (Link)	IR647	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD31, Endothelial Cell Cl JC70A RTU (Dako Omnis)	GA610	FDA UDI	Class I	Active
Poly Rb A-Hu c-erbB-2 Oncoprotein	A0485	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu BCL6 Protein Cl PG-B6p RTU	IS625	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD68 Cl PG-M1 RTU	IS613	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD45, Leucocyte Common Antigen Cls 2B11 + PD7/26 RTU	IS751	FDA UDI	Class I	Unknown
FLEX Mono Mo A-Hu Cytokeratin 19 Cl RCK108 RTU	IS615	FDA UDI	Class I	Active
Mono Mo A-Hu Follicular Dendritic Cell Cl CNA.42	M7157	FDA UDI	Class I	Active
Poly Rb A-Hu Prealbumin	A0002	FDA UDI	Class I	Active
Mono Mo A-Hu CD79acy/APC Cl HM57	C7252	FDA UDI	Class I	Active
Poly Rb A-Hu C4c Complement/FITC	F0169	FDA UDI	Class II	Active
Mono Mo a Hu CD45R0/RPE, Cl UCHL1	R0843	FDA UDI	Class I	Active
Mono Mo A-Hu CD34 Class III/FITC Cl BIRMA-K3	F7081	FDA UDI	Class I	Active
Mono Mo A-Hu CD44, Phagocytic Glycoprotein-1 Cl DF1485	M7082	FDA UDI	Class I	Active
Mono Mo A-Hu CD68 Cl PG-M1	M0876	FDA UDI	Class I	Active
Dako Omnis 165	GI400	FDA UDI	Class I	Active
Mono Mo a Hu CD5/RPE, Cl DK23	R0842	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD246 ALK Protein Cl ALK1 RTU	IS641	FDA UDI	Class I	Active
Mono Mo A-Proliferating Cell Nuclear Antigen Cl PC10	M0879	FDA UDI	Class I	Active
Mono Mo a Hu CD7/FITC, Cl CBC.37	F7276	FDA UDI	Class I	Active
Mono Mo A-Enterovirus Cl 5-D8/1	M7064	FDA UDI	Class I	Active
Poly Rb A-Hu IgG	A0424	FDA UDI	Class II	Active
Mono Mo A-Hu CD8 Cl C8/144B	M7103	FDA UDI	Class I	Active
Mono Mo A-Hu CD20/FITC Cl B-Ly1	F0799	FDA UDI	Class I	Active
Mono Mo A-Hu p27Kip1 Cl SX53G8	M7203	FDA UDI	Class I	Active
Mono Mo a Hu CD20/RPE, Cl B-Ly1	R7013	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD31, Endothelial Cell Cl JC70A RTU (Link)	IR610	FDA UDI	Class I	Active
Mono Mo A-Hu CD15/FITC Cl C3D-1	F0830	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu Gastrin RTU (Dako Omnis)	GA519	FDA UDI	Class I	Active
Dako CoverStainer	CS100	EUDAMEDFDA UDI	Class I	Active
FLEX Mono Mo A-Hu Mast Cell Tryptase Cl AA1 RTU (Link)	IR640	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1 RTU	IS702	FDA UDI	Class I	Active
Mono Mo A-Rb Immunoglobulins Cl MR12/53	M0737	FDA UDI	Class I	Active
Poly Rb A-Hu Fibrinogen/FITC	F0111	FDA UDI	Class II	Active
FLEX Mono Mo A-Hu MLH1, Cl ES05 RTU (Dako Omnis)	GA079	EUDAMEDFDA UDI	Class I	Active
Poly Rb A-Hu Fibrinogen	A0080	FDA UDI	Class II	Active
Poly Rb A-Hu Alpha-1-Fetoprotein	A0008	FDA UDI	Class I	Active
FLEX Mono Rb A-Hu ERG Cl EP111 RTU (Link)	IR659	FDA UDI	Class I	Active
Mono Mo A-Cytokeratin 17 Cl E3	M7046	FDA UDI	Class I	Active
Mono Mo a Hu Ki-67 Antigen/FITC, Cl MIB-1	F7268	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD79a Cl JCB117 RTU (Dako Omnis)	GA621	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD56 Cl 123C3 RTU (Link)	IR628	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu Calcitonin RTU (Link)	IR515	FDA UDI	Class I	Active
Mono Mo A-Hu CD8/FITC Cl DK25	F0765	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Melan-A Cl A103 RTU	IS633	FDA UDI	Class I	Active

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