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EMD MILLIPORE CORPORATION

Last updated September 17, 2026

Information

Country: US
Address: 400 Summit Drive, Burlington, MA, 01803
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2244894
DUNS Number: —

Catalogue (155)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
Light Diagnostics ™ SimulFluor® Respiratory Screen Kit	3296-2ML	FDA UDI	Class I	Unknown
Light Diagnostics HSV 1 & 2 Control Slide	5093	FDA UDI	Class II	Unknown
Light Diagnostics ™ Adenovirus Control Slide	5009	FDA UDI	Class I	Unknown
Light Diagnostics™ Respiratory Syncytial Virus DFA Kit	3125	FDA UDI	Class I	Unknown
Light Diagnostics ™ Respiratory Screen DFA Reagent	5307	FDA UDI	Class I	Unknown
Light Diagnostics™ SimulFluor® RSV/Para 3 DFA Kit	3127	FDA UDI	Class I	Unknown
Light Diagnostics ™ Echovirus Control Slide	50207	FDA UDI	Class I	Unknown
Light Diagnostics ™ Poliovirus Control Slide	50206	FDA UDI	Class I	Unknown
Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control Slides	5012-5	FDA UDI	Class I	Unknown
Light Diagnostics SimulFluor HSV/VZV Reagent	5235	FDA UDI	Class II	Unknown
Light Diagnostics ™ Mouse Anti-Cytomegalovirus Monoclonal Antibody	MAB810	FDA UDI	Class I	Unknown
Light Diagnostics™ Pneumocystis Carinii DFA	3195	FDA UDI	Class II	Unknown
Light Diagnostics CMV Control Slide	5027	FDA UDI	Class II	Unknown
Light Diagnostics™ SimulFluor® Para 1, 2, 3/ Adeno DFA Kit	3299	FDA UDI	Class I	Unknown
Light Diagnostics ™ Pan-Enterovirus 9D5	3361	FDA UDI	Class I	Unknown
Light Diagnostics CMV Control Slides (5 pack)	5027-5	FDA UDI	Class II	Unknown
Light Diagnostics HSV 1 Typing Reagent	5233	FDA UDI	Class II	Unknown
Light Diagnostics™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C15-62-97-3	MAB8723	FDA UDI	Class I	Unknown
Light Diagnostics™ Mumps IFA Kit	3140	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackievirus B4 Monoclonal Antibody	3307	FDA UDI	Class I	Unknown
Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence Assay	3121	FDA UDI	Class I	Unknown
Light Diagnostics ™ Pan-Enterovirus Reagent	3360-10ML	FDA UDI	Class I	Unknown
Light Diagnostics ™ Parainfluenza 1 FITC-Labeled Monoclonal Antibody	5019	FDA UDI	Class I	Unknown
Light Diagnostics HSV 2 Typing Reagent	5234	FDA UDI	Class II	Unknown
Light Diagnostics ™ Rabies Negative Control Concentrate	5102	FDA UDI	Class II	Unknown
Light Diagnostics ™ Parainfluenza 1, 2, 3 Control Slides	5011-5	FDA UDI	Class I	Unknown
Light Diagnostics™ Coxsackievirus A24 Monoclonal Antibody	3302	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackievirus B1 Monoclonal Antibody	3304	FDA UDI	Class I	Unknown
Light Diagnostics ™ SimulFluor® Respiratory Screen Reagent	5296-2ML	FDA UDI	Class I	Unknown
Light Diagnostics ™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C2-62-8-2	MAB8719	FDA UDI	Class I	Unknown
Light Diagnostics™ SimulFluor® Parainfluenza 1, 2 /3 DFA Kit	3297	FDA UDI	Class I	Unknown
Light Diagnostics ™ Enterovirus Screening Kit	3465	FDA UDI	Class I	Unknown
Light Diagnostics ™ SimulFluor® Respiratory Screen Reagent	5296	FDA UDI	Class I	Unknown
Light Diagnostics ™ Parainfluenza 3 FITC-Labeled Monoclonal Antibody	5021	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackievirus B6 Monoclonal Antibody	3309	FDA UDI	Class I	Unknown
Light Diagnostics ™ Adenovirus Control Slides	5009-5	FDA UDI	Class I	Unknown
Light Diagnostics ™ Poliovirus 2 Monoclonal Antibody	3332	FDA UDI	Class I	Unknown
Light Diagnostics ™ Echovirus 6 Monoclonal Antibody	3312	FDA UDI	Class I	Unknown
Light Diagnostics ™ RSV FITC-Labeled Monoclonal Antibody	5022	FDA UDI	Class I	Unknown
Light Diagnostics™ Rabies DFA Reagent	5100	FDA UDI	Class II	Unknown
Light Diagnostics™ Coxsackievirus A9 Monoclonal Antibody	3301	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackie B Control Slide	50208	FDA UDI	Class I	Unknown
Light Diagnostics hMPV Control Slide	5092	FDA UDI	Class II	Unknown
Light Diagnostics ™ Measles Control Slides	5031-5	FDA UDI	Class I	Unknown
Light Diagnostics ™ Pan-Enterovirus 2E11 Monoclonal Antibody	3362	FDA UDI	Class I	Unknown
Light Diagnostics ™ Measles Control Slide	5031	FDA UDI	Class I	Unknown
Light Diagnostics ™ Goat Anti-Mouse IgG FITC-Labeled Antibody	5008	FDA UDI	Class I	Unknown
Light Diagnostics ™ Influenza A Monoclonal Antibody	5001	FDA UDI	Class I	Unknown
Light Diagnostics ™ Enterovirus 71 Monoclonal Antibody	3324	FDA UDI	Class I	Unknown
Light Diagnostics ™ Respiratory Viral Control Slides (8 Well)	5071-10	FDA UDI	Class I	Unknown

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 26, 2024	Z-1185-2024	—	open, classified	This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
Oct 17, 2023	Z-0408-2024	—	open, classified	Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.