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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 1 of 4

Device	Model / Reference	Registries	Class	Status
Light Diagnostics ™ Para 4 DFA Reagent	5034	FDA UDI	Class I	Unknown
Light Diagnostics ™ Rabies Diluent Reagent	5070	FDA UDI	Class II	Unknown
Light Diagnostics SimulFluor HSV 1/2	5243-2mL	FDA UDI	Class II	Unknown
Light Diagnostics ™ Respiratory syncytial Virus (RSV) Control Slide	5012	FDA UDI	Class I	Unknown
Light Diagnostics™ Varicella- Zoster Virus DFA Kit	3430	FDA UDI	Class II	Active
Light Diagnostics ™ Parainfluenza 2 Monoclonal Antibody	5005	FDA UDI	Class I	Unknown
Light Diagnostics ™ Enterovirus 71/ Coxsackie A16 Monoclonal Antibody	3323	FDA UDI	Class I	Unknown
Light Diagnostics™ Respiratory Viral Screen IFA Kit	3108	FDA UDI	Class I	Unknown
Light Diganostics ™ Echovirus Blend Monoclonal Antibodies	3311	FDA UDI	Class I	Unknown
Light Diagnostics PCP DFA Reagent	5195	FDA UDI	Class II	Unknown
Light Diagnostics ™ Enterovirus Screening Set	3365	FDA UDI	Class I	Unknown
Light Diagnostics ™ Echovirus 9 Monoclonal Antibody	3313	FDA UDI	Class I	Unknown
Light Diagnostics VZV Control Slides (5 pack)	5088-5	FDA UDI	Class II	Unknown
Light Diagnostics HSV 1 & 2 Control Slides (5 Pack)	5093-5	FDA UDI	Class II	Unknown
Light Diagnostics ™ Respiratory Viral Control Slide	5071	FDA UDI	Class I	Unknown
MIDAS® III-Plus Automated Stainer	64000H-94	FDA UDI	Class I	Unknown
Light Diagnostics CMV DFA Reagent	5090-2ML	FDA UDI	Class II	Unknown
Light Diagnostics ™ Coxsackievirus B2 Monoclonal Antibody	3305	FDA UDI	Class I	Unknown
Light Diagnostics ™ Parainfluenza 2 Monoclonal Antibody	5004	FDA UDI	Class I	Unknown
Light Diagnostics ™ Mumps Monoclonal Antibody	5028	FDA UDI	Class I	Unknown
Light Diagnostics ™ SimulFluor® Flu A/Flu B Reagent	5250	FDA UDI	Class I	Unknown
Light Diagnostics ™ Pan-Enterovirus Detection Kit	3460	FDA UDI	Class I	Unknown
Light Diagnostics™ Influenza A and B DFA Kit	3123	FDA UDI	Class I	Unknown
Light Diagnostics VZV DFA Reagent	5094	FDA UDI	Class II	Unknown
Light Diagnostics ™ Pan-Enterovirus Control Slide	5069	FDA UDI	Class I	Unknown
Light Diagnostics™ SimulFluor® Respiratory Screen Kit	3296	FDA UDI	Class I	Unknown
Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent	5250-5ML	FDA UDI	Class I	Unknown
Light Diagnostics™ Parainfluenza 1, 2, and 3 DFA Kit	3120	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackie A9/A24 Control Slide	50209	FDA UDI	Class I	Unknown
Light Diagnostics ™ Poliovirus 3 Monoclonal Antibody	3335	FDA UDI	Class I	Unknown
Light Diagnostics VZV Control Slide	5088	FDA UDI	Class II	Unknown
Light Diagnostics Human Metapneumovirus (hMPV) Control Slides (5 pack)	5092-5	FDA UDI	Class II	Unknown
Light Diagnostics ™ Para 4 Control Slide	5098	FDA UDI	Class I	Unknown
Light Diagnostics ™ Echovirus 11 Monoclonal Antibody	3314	FDA UDI	Class I	Unknown
Light Diagnostics™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C10-62-52-2	MAB8722	FDA UDI	Class I	Unknown
Light Diagnostics™ CMV DFA Kit	3245	FDA UDI	Class II	Unknown
Light Diagnostics™Mouse Anti-Rabies Monoclonal Antibody; Clone Name C18-62-143-2	MAB8724	FDA UDI	Class I	Unknown
Light Diagnostics ™ SimulFluor® Para 1, 2, 3/ Adeno Reagent	5299	FDA UDI	Class I	Unknown
Light Diagnostics ™ Rabies DFA III Reagent	6500	FDA UDI	Class I	Unknown
Light Diagnostics™ Measles IFA Kit	3187	FDA UDI	Class I	Unknown
Light Diagnostics ™ CMV pp65 Monoclonal Antibody	5097	FDA UDI	Class I	Unknown
Light Diagnostics ™ Influenza B Monoclonal Antibody	5002	FDA UDI	Class I	Unknown
Light Diagnostics ™ Mouse Anti-Cytomegalovirus Monoclonal Antibody	MAB810-500UG	FDA UDI	Class I	Unknown
Light Diagnostics™Mouse Anti-Rabies Monoclonal Antibody; Clone Name CR54-6229-54	MAB8717	FDA UDI	Class I	Unknown
Light Diagnostics ™ SimulFluor® RSV/Para 3 Reagent	5240	FDA UDI	Class I	Unknown
Light Diagnostics ™ Mumps Control Slide	5029	FDA UDI	Class I	Unknown
Light Diagnostics ™ Mumps Control Slides	5029-5	FDA UDI	Class I	Unknown
Light Diagnostics ™ Influenza A & B Control Slides	5010-5	FDA UDI	Class I	Unknown
Light Diagnostics ™ Enterovirus70/71 Control Slide	50266	FDA UDI	Class I	Unknown
Light Diagnostics™ Respiratory Viral Screen DFA Kit	3107	FDA UDI	Class I	Unknown

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Notified Bodies

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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.