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Fisher Diagnostics

Last updated September 17, 2026

Information

Country: US
Address: 8365 VALLEY PIKE, MIDDLETOWN, VA, 22645
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1181121
DUNS Number: —

Catalogue (132)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Thermo Scientific Infinity™	TR85201	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100250	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401223PA	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401272P	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100900	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100304	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401207P	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100308	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100251	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401526P	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-31	FDA UDI	Class I	Active
Thermo Scientific Trutol™	401074P	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100644	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-40	FDA UDI	Class I	Active
Thermo Scientific Nerl®	9805	FDA UDI	Class I	Active
Thermo Scientific Infinity™	TR66901	FDA UDI	Class II	Active
Architect Anti-Tg Immunoassay Reagents, Calibrators, Controls And System Assay Cd-Rom	K052308	FDA 510(k)	Class II	Active
Fisher Diagnostics Sera Chem Smac Calibrators	K844047	FDA 510(k)	Class II	Active
Toxi Chem Serum Alcohol Control	K833514	FDA 510(k)	Class I	Active
Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560	K010750	FDA 510(k)	Class II	Active
Therachem Tdc Therapeutic Drug Control	K840921	FDA 510(k)	Class I	Active
Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin	K023362	FDA 510(k)	Class II	Active
Fisher Diagnostics Pregnaclone Slide Pregnancy Tes	K844346	FDA 510(k)	Class II	Active
Architect Stat Myo Immunoassay	K042924	FDA 510(k)	Class II	Active
Architect Stat Ck-Mb Immunoassay	K041596	FDA 510(k)	Class II	Active
Fisher Diag. Pregnaclone Tube Pregnancy Test Kit	K844347	FDA 510(k)	Class II	Active
Architect Stat Troponin-1; Myoglobin	K070640	FDA 510(k)	Class II	Active
ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls	K170652	FDA 510(k)	Class II	Active
Fisher Diagnostics Latest-Crp Test Kit	K850160	FDA 510(k)	Class II	Active
Architect Anti-Tpo Immunoassay, Calibrators & Controls	K052407	FDA 510(k)	Class II	Active
Pacific Hemostasis Reference Emulsion	K013397	FDA 510(k)	Class II	Active
Architect Stat Troponin-I Immunoassay	K041192	FDA 510(k)	Class II	Active

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FDA Recalls (4)

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
Mar 6, 2025	Z-1502-2025	—	open, classified	The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Mar 6, 2025	Z-1503-2025	—	open, classified	The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
May 19, 2017	Z-2763-2017	—	terminated	An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.
May 19, 2017	Z-2762-2017	—	terminated	An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.