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DIAMOND DIAGNOSTICS Inc

United States·US-MF-000035435

Last updated September 17, 2026

Information

Country
United States
Address
333, FISKE STREET, HOLLISTON, United States
LinkedIn
—
Facebook
—
Phone
+16173839917
PRRC Contact
DELOVE NADUTEY
EUDAMED SRN
US-MF-000035435
FDA FEI Number
3003030793
DUNS Number
—

Catalogue (310)

Page 2 of 7
DeviceModel / ReferenceRegistriesClassStatus
Electrode AV-BP1237D
EUDAMEDFDA UDI
Class AActive
Standard solution RO-4522320D
EUDAMEDFDA UDI
Class AActive
Buffer solution BT-6620942AD
EUDAMED
Class AActive
Scanner DD-0202
EUDAMED
Class AActive
Bath oil SM-B01418001D
EUDAMEDFDA UDI
Class AActive
Standard solution BM-620427D
EUDAMEDFDA UDI
Class AActive
Standard solution SM-B03417501BD
EUDAMED
Class AActive
Electrode ME-2103D
EUDAMEDFDA UDI
Class AActive
Syringe OY-ZM0016D
EUDAMED
Class AActive
Electrode AW-903394D
EUDAMEDFDA UDI
Class AActive
Compressor rebuild kit SX-44368656D
EUDAMEDFDA UDI
Class AActive
Reference solution OY-AUH1013D
EUDAMEDFDA UDI
Class AActive
Cleaning solution BM-1135329D
EUDAMEDFDA UDI
Class AActive
Mission Control Kit DD-92123
EUDAMEDFDA UDI
Class AActive
Electrode RD-945375D
EUDAMEDFDA UDI
Class AActive
Wiper kit ME-2323D
EUDAMED
Class AActive
Selectivity check OY-AUH1018D
EUDAMEDFDA UDI
Class AActive
Mission complete kit DD-92900
EUDAMEDFDA UDI
Class AActive
Electrode AV-BP0570D
EUDAMEDFDA UDI
Class AActive
Calibration solution AW-SA1029D
EUDAMEDFDA UDI
Class AActive
Wash solution CD-473497D
EUDAMEDFDA UDI
Class AActive
Valve ME-2108D
EUDAMEDFDA UDI
Class AActive
Lamp OY-MU8550D
EUDAMEDFDA UDI
Class AActive
Buffer solution OY-AUH1011D
EUDAMEDFDA UDI
Class AActive
Standard solution SM-B03417501D
EUDAMEDFDA UDI
Class AActive
Cuvette cartridge DA-D828D
EUDAMED
Class AActive
Calibrator solution DD-97123
EUDAMEDFDA UDI
Class AActive
Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level 2, Mission C K124009
FDA 510(k)
Class IActive
Gemlyte Electrolyte Analyzer Na+/K+/Cl-/ca++/Li+ K082462
FDA 510(k)
Class IIActive
Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical Calibrator K093492
FDA 510(k)
Class IActive
Creatinine Reagent Kit For Beckman Synchron Cx & Cx Delta Systems K033058
FDA 510(k)
Class IIActive
Diamond Calibrator Low, Diamond Calibrator High K121027
FDA 510(k)
Class IIActive
Mission Complete K060206
FDA 510(k)
Class IActive
Glucose Reagent For Beckman Synchron Cx & Cx Delta Systems K033055
FDA 510(k)
Class IIActive
Mission Trinity B K062674
FDA 510(k)
Class IActive
Mission Trinity R (level 1) (level 2) (level 3), (level 1, 2, 3) K093384
FDA 510(k)
Class IActive
Smartlyte Electrolyte Analyzer K121040
FDA 510(k)
Class IIActive
Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards K133751
FDA 510(k)
Class IIActive
Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level K103364
FDA 510(k)
Class IActive
Calibrating Material, Calibrating Standards K031159
FDA 510(k)
Class IIActive
Bun Reagent For Beckman Synchron Cx & Cx Delta Reagent K033056
FDA 510(k)
Class IIActive
Calibrating Material, Calibrating Standards K033060
FDA 510(k)
Class IIActive
Calibrating Material, Ise Electrolyte Reference K033061
FDA 510(k)
Class IIActive
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ K200544
FDA 510(k)
Class IIActive
Diamond Tokyo Boeki Ise Module Calibrator 1, 2, 1-2 K120591
FDA 510(k)
Class IIActive
Mission Olympus Au Ise Calibrators K071039
FDA 510(k)
Class IIActive
Calibrating Material, Cal-Pak, Cal & Slope Standards K020596
FDA 510(k)
Class IIActive
Diamond Medica Ise Module Calibrant A Model Me-6370d, Diamond Medica Ise Module Calibrant B, Model Me-5410d K093357
FDA 510(k)
Class IIActive
Peristaltic Pump UNITY 1PK DD-61101
EUDAMED
Class AActive
Syringe OY-ZM0111D
EUDAMEDFDA UDI
Class AActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Diamond Diagnostics Inc. Budapest · HU FEI 3006198300