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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
Cystatin C Control Set	X0973	FDA UDI	Class I	Unknown
FLEX Mono Mo A-Hu MUM1 Protein Cl MUM1p RTU	IS644	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD4 Cl 4B12 RTU (Link)	IR649	FDA UDI	Class I	Active
Mono Mo a Hu CD3/PerCP, Cl UCHT1	PR702	FDA UDI	Class I	Active
Mono Mo A-Hu Cytokeratin 20 Cl Ks20.8	M7019	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CA 125 Cl M11 RTU (Link)	IR701	FDA UDI	Class I	Active
Mono Mo A-Hu Neuron-Specific Enolase Cl BBS/NC/VI-H14	M0873	FDA UDI	Class I	Active
Mono Mo a Hu CD8/PB, Cl DK25	PB984	FDA UDI	Class I	Active
Mono Mo a Hu CD64, Fc Gamma Receptor I/RPE, Cl 10.1	R7219	FDA UDI	Class I	Active
Mono Mo A-Hu Synaptophysin Cl DAK-SYNAP	M7315	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD43 Cl DF-T1 RTU	IS636	FDA UDI	Class I	Active
FLEX Mono Rb A-Hu ERG Cl EP111 RTU (Dako Omnis)	GA659	FDA UDI	Class I	Active
Mono Mo A-Hu p53 Protein Cl DO-7	M7001	FDA UDI	Class I	Active
Poly Rb A-Hu Kappa LC/FITC	F0198	FDA UDI	Class II	Active
Mono Mo A-Hu CD5/APC Cl DK23	C7242	FDA UDI	Class I	Active
Mono Mo a Hu CD19/PerCP-Cy5.5	PR703	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Nucleophosmin Cl 376 RTU (Link)	IR652	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu IgG, RTU (Dako Omnis)	GA512	FDA UDI	Class I	Active
Poly Rb A-Glial Fibrillary Acidic Protein	Z0334	FDA UDI	Class I	Active
Mono Mo A-Hu CD57 Cl TB01	M7271	FDA UDI	Class I	Active
Mono Mo A-Hu Cytokeratin 10/13 Cl DE-K13	M7003	FDA UDI	Class I	Active
Mono Mo A-Hu CD3/RPE-Cy5, Cl UCHT1	C7067	FDA UDI	Class II	Active
Mono Mo a Hu CD45, Leucocyte Common Antigen/PerCP, Cl 2D1	PR701	FDA UDI	Class I	Active
Mono Mo a Hu CD45, Leucocyte Common Antigen/PB, Cl T29/33	PB986	FDA UDI	Class I	Active
Mono Mo A-Hu CD33/FITC Cl WM-54	F0832	FDA UDI	Class I	Active
Mono Mo a Hu CD11c, Protein 150, 95/ FITC, Cl KB90	F0713	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Amyloid A Cl mc1 RTU (Dako Omnis)	GA605	FDA UDI	Class I	Active
Dako Omnis Waste Accessories (Direct)	GC123	EUDAMEDFDA UDI	Class I	Active
FLEX Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1 RTU (Dako Omnis)	GA702	FDA UDI	Class I	Active
FLEX Poly Rb A-Hu Thyroglobulin RTU (Link)	IR509	FDA UDI	Class I	Active
Mono Mo A-Hu Melan-A Cl A103	M7196	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Neuron-Specific Enolase Cl BBS/NC/VI-H14 RTU (Link)	IR612	FDA UDI	Class I	Active
Mono Mo A-Hu HLA-DP, DQ, DR Antigen/FITC Cl CR3/43	F0817	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu p16 Clone JC8 RTU (Dako Omnis)	GA783	FDA UDI	Class I	Active
Mono Mo A-Hu Ki-67 Antigen Cl MIB-1	M7240	FDA UDI	Class I	Active
Mono Mo A-Sarcomeric Actin Cl Alpha-Sr-1	M0874	FDA UDI	Class I	Active
Mono Mo A-Hu Calretinin Cl DAK-Calret 1	M7245	FDA UDI	Class I	Active
Poly Rb A-Hu Lambda Free LC	A0101	FDA UDI	Class II	Active
Mono Mo a Hu CD38/RPE, Cl AT13/5	R7144	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu Ki-67 Antigen Cl MIB-1 RTU (Dako Omnis)	GA626	FDA UDI	Class I	Active
Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7	M7072	FDA UDI	Class I	Active
Autostainer Link 48	AS480	EUDAMEDFDA UDI	Class I	Active
HercepTest™ for Automated Link Plarforms	SK001	FDA UDI	Class III	Active
Polyclonal Rabbit Anti - S100	Z0311	FDA UDI	Class I	Unknown
FLEX Mono Mo A-Hu CD19 Cl LE-CD19 RTU (Link)	IR656	FDA UDI	Class I	Active
Mono Mo a Hu CD3/PB, Cl UCHT1	PB982	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CD21 Cl 1F8 RTU	IS608	FDA UDI	Class I	Active
FLEX Mono Rb A-Hu p40, Clone DAK-p40, RTU (Dako Omnis)	GA784	EUDAMEDFDA UDI	Class I	Active
FLEX Poly Rb A-Hu Myeloperoxidase RTU (Link)	IR511	FDA UDI	Class I	Active
FLEX Poly Rb A-S100 RTU (Dako Omnis)	GA504	FDA UDI	Class I	Active

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