Is this your brand? Sign in to claim ownership.

Fisher Diagnostics

Last updated September 17, 2026

Information

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

Catalogue (132)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Thermo Scientific	1245250	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-9A	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-3A	FDA UDI	Class II	Active
Thermo Scientific Infinity™	TR15421	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100050	FDA UDI	Class II	Active
Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems	OL66001	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-6A	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-45	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100353	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-28	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100656	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-10A	FDA UDI	Class II	Active
Thermo Scientific Infinity™	TR60901	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100606	FDA UDI	Class II	Active
Thermo Scientific GlucoCrush™	B2495-2A	FDA UDI	Class II	Active
Thermo Scientific	TR33321	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	102000	FDA UDI	Class II	Active
Thermo Scientific	TR34026	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-44	FDA UDI	Class I	Active
Thermo Scientific	TR11320	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100301	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-51	FDA UDI	Class I	Active
Thermo Scientific Infinity™ for Olympus Analyzers	TR66002	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100800	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100596	FDA UDI	Class II	Active
Thermo Scientific Infinity™	1265250	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-33	FDA UDI	Class I	Active
Thermo Scientific Protocol™ Parasitology System	23-005-26	FDA UDI	Class I	Active
Thermo Scientific Infinity™	TR28321	FDA UDI	Class II	Active
Thermo Scientific Infinity™	TR35121	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401503P	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100314	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100362	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401223PS	FDA UDI	Class II	Active
Thermo Scientific Nerl®	JDIL5522	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100011	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401576P	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100560	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-47	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100650	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-37	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100258	FDA UDI	Class II	Active
Thermo Scientific Trutol™	401025P	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	100604	FDA UDI	Class II	Active
Thermo Scientific	TR14314	FDA UDI	Class II	Active
Thermo Scientific Pacific Hemostasis®	101000	FDA UDI	Class II	Active
Thermo Scientific Protocol™ Parasitology System	23-005-43	FDA UDI	Class I	Active
Thermo Scientific Pacific Hemostasis®	100647	FDA UDI	Class II	Active
Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems	OL60101	FDA UDI	Class I	Active
Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems	A19611	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.