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EMD MILLIPORE CORPORATION

Last updated September 17, 2026

Information

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

Catalogue (155)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Light Diagnostics ™ Poliovirus Antibody Set	3355	FDA UDI	Class I	Unknown
Light Diagnostics ™ Rabies DFA II Reagent	5500	FDA UDI	Class I	Unknown
Light Diagnostics ™ Parainfluenza 4 Control Slides (5 Pack)	5098-5	FDA UDI	Class I	Unknown
Light Diagnostics ™ Adenovirus Monoclonal Antibody	5000	FDA UDI	Class I	Unknown
Light Diagnostics SimulFluor HSV 1/HSV 2 Reagent	5243	FDA UDI	Class II	Unknown
Light Diagnostics ™ Echovirus Control Slides	5074	FDA UDI	Class I	Unknown
Light Diagnostics ™ Enterovirus 70 Monoclonal Antibody	3322	FDA UDI	Class I	Unknown
Light Diagnostics ™ Pan-Enterovirus Control Slides	5069-5	FDA UDI	Class I	Unknown
Light Diagnostics hMPV DFA Reagent	5091	FDA UDI	Class II	Unknown
Light Diagnostics ™ RSV Monoclonal Antibody	5006	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackievirus A Control Slides	5076	FDA UDI	Class I	Unknown
Light Diagnostics ™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C1 62-3-1	MAB8718	FDA UDI	Class I	Unknown
Light Diagnostics™ Respiratory Panel Viral Screening and Identification DFA Kit	3137	FDA UDI	Class I	Unknown
Light Diagnostics ™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C4-62-15-2	MAB8716	FDA UDI	Class I	Unknown
Light Diagnostics CMV IFA Reagent	5026	FDA UDI	Class II	Unknown
Light Diagnostics™ Human Metapneumovirus Direct Immunofluorescence Assay	3124	FDA UDI	Class II	Unknown
Light Diagnostics ™ Parainfluenza Pan FITC-Labeled Monoclonal Antibodies	5025	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackievirus B3 Monoclonal Antibody	3306	FDA UDI	Class I	Unknown
Light Diagnostics ™ Echovirus Antibody Set	3340	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackie Antibody Set	3350	FDA UDI	Class I	Unknown
Light Diagnostics ™ Measles Monoclonal Antibody	5030	FDA UDI	Class I	Unknown
Light Diagnostics ™ Enterovirus Slide Package	5077	FDA UDI	Class I	Unknown
Light Diagnostics™ HSV 1&2 Typing DFA Kit	3291	FDA UDI	Class II	Unknown
Light Diagnostics ™ Enterovirus 70/71 Control Slides	5066	FDA UDI	Class I	Unknown
Light Diagnostics ™ Echovirus 30 Monoclonal Antibody	3315	FDA UDI	Class I	Unknown
Light Diagnostics™ Respiratory Panel Viral Screening and Identification IFA Kit	3105	FDA UDI	Class I	Unknown
Light Diagnostics™ Simulfluor® HSV 1/ HSV 2 DFA Kit	3293	FDA UDI	Class II	Unknown
Light Diagnostics ™ Respiratory Viral Screen	5007	FDA UDI	Class I	Unknown
Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal Antibody	5017	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackievirus B Control Slides	5075	FDA UDI	Class I	Unknown
Light Diagnostics ™ Poliovirus 1 Monoclonal Antibody	3331	FDA UDI	Class I	Unknown
Light Diagnostics ™ Para-influenza 1, 2, 3 Control Slide	5011	FDA UDI	Class I	Unknown
Light Diagnostics ™ Influenza A & B Control Slide	5010	FDA UDI	Class I	Unknown
Light Diagnostics ™ Normal Mouse Antibody	5014	FDA UDI	Class I	Unknown
Light Diagnostics Anti-mouse IGG:FITC	5024	FDA UDI	Class II	Unknown
Light Diagnostics ™ Poliovirus Blend	3336	FDA UDI	Class I	Unknown
Light Diagnostics ™ Parainfluenza 1 Monoclonal Antibody	5003	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackievirus B Blend Monoclonal Antibodies	3303	FDA UDI	Class I	Unknown
Light Diagnostics ™ Enterovirus 70 and 71 or Coxsackie A16 Blend	3321	FDA UDI	Class I	Unknown
Light Diagnostics ™ Adenovirus FITC-Labeled Monoclonal Antibody	5016	FDA UDI	Class I	Unknown
Light Diagnostics ™ Coxsackievirus B5 Monoclonal Antibody	3308	FDA UDI	Class I	Unknown
Light Diagnostics ™ Respiratory Screen DFA Reagent	5307-2ML	FDA UDI	Class I	Unknown
Light Diagnostics ™ Echovirus 4 Monoclonal Antibody	3317	FDA UDI	Class I	Unknown
Light Diagnostics ™ Poliovirus Control Slides	5067	FDA UDI	Class I	Unknown
Light Diagnostics ™ SimulFluor® Parainfluenza 1, 2/3 Reagent	5297	FDA UDI	Class I	Unknown
Light Diagnostics™ CMV IFA Kit	3135	FDA UDI	Class II	Unknown
Light Diagnostics™ Respiratory Panel DFA Kit	3110	FDA UDI	Class I	Unknown
Light Diagnostics ™ Enterovirus 70/71 Antibody Set	3345	FDA UDI	Class I	Unknown
Light Diagnostics ™ Parainfluenza 2 FITC-Labeled Monoclonal Antibody	5020	FDA UDI	Class I	Unknown
Light Diagnostics ™ Pan-Enterovirus Reagent	3360	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.