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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Thermo Scientific Pacific Hemostasis®	101100	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-41	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100240	FDA UDI	Class II	Active
Thermo Scientific for Beckman Coulter SYNCHRON and UnuCel Systems	A46660	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100354	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-4A	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-68	FDA UDI	Class I	Active
Thermo Scientific Infinity™	TR50001	FDA UDI	Class II	Active
Thermo Scientific Nerl®	8505	FDA UDI	Class I	Active
Thermo Scientific	TS3000	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-50	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100600	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100312	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-39	FDA UDI	Class I	Active
Thermo Scientific Infinity™ for Beckman Coulter AU® Chemistry Analyzers	106517	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100806	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100357	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	101200	FDA UDI	Class II	Active
Thermo Scientific	TR14010	FDA UDI	Class II	Active
Thermo Scientific Nerl®	8504	FDA UDI	Class I	Active
Thermo Scientific Infinity™	TR70121	FDA UDI	Class II	Active
Thermo Scientific Infinity™	TR85056	FDA UDI	Class II	Active
Thermo Scientific	TR36026	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401272PA	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100595	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401009P	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-7A	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-27	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100601	FDA UDI	Class II	Active
Thermo Scientific Infinity™	TR12421	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100654	FDA UDI	Class II	Active
Thermo Scientific	TR20015	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100603	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-32	FDA UDI	Class I	Active
Thermo Scientific Infinity™	TR66056	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401223P	FDA UDI	Class II	Active
Thermo Scientific Infinity™	TR25421	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-30	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100651	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-38	FDA UDI	Class I	Active
Thermo Scientific Protocol™ Parasitology System	23-005-46	FDA UDI	Class I	Active
Thermo Scientific Infinity™	TR15221	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100070	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-5A	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100013	FDA UDI	Class II	Active
Thermo Scientific Nerl®	9800-3	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100665	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100602	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-1A	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100309	FDA UDI	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.