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Sign in to claim this brandEMD MILLIPORE CORPORATION
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 400 Summit Drive, Burlington, MA, 01803
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2244894
- DUNS Number
- —
Catalogue (155)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Light Diagnostics™ Simulfluor® HSV / VZV DFA | 3295 | FDA UDI | Class II | Unknown |
| Light Diagnostics CMV DFA Reagent | 5090 | FDA UDI | Class II | Unknown |
| Light Diagnostics ™ Influenza B Monoclonal Antibody | 5018 | FDA UDI | Class I | Unknown |
| Light Diagnostics Mouse Anti-CMV Monoclonal Antibody | 5026-2ML | FDA UDI | Class II | Unknown |
| Light Diagnostics™ Adenovirus DFA Kit | 3130 | FDA UDI | Class I | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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. |