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Thermo Fisher Scientific

Last updated May 23, 2026

What Thermo Fisher Scientific makes

Thermo Fisher Scientific manufactures automated specimen processing instruments for laboratory use, including recappers and storage systems, as well as multiple clinical chemistry analysers for routine laboratory testing. Their portfolio includes susceptibility testing systems for antimicrobial resistance, such as MIC/Breakpoint plates and systems for antibiotics like ceftolozane/tazobactam, imipenem-relebactam, and cefiderocol. Additional products include immunoassay analysers for allergen and immunoglobulin testing, as well as yeast susceptibility testing systems for antifungal agents.

These devices are regulated under FDA Class I and Class II classifications, with many authorised via the 510(k) pathway and listed under the FDA’s Unique Device Identifier (UDI) system. The company’s products are intended for in vitro diagnostic use in clinical and research settings.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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Catalogue (81)

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Device	Model / Reference	Registries	Class	Status
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL	K193024	FDA 510(k)	Class II	Active
Qms Lidocaine Calibrators, Model 0374678	K091617	FDA 510(k)	Class II	Active
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL	K211539	FDA 510(k)	Class II	Active
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)	K202612	FDA 510(k)	Class II	Active
Calcium, Scal, Nortrol, Abtrol	K073355	FDA 510(k)	Class II	Active
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)	K142338	FDA 510(k)	Class II	Active
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL	K172454	FDA 510(k)	Class II	Active
Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls	K081083	FDA 510(k)	Class II	Active
Thermo Scientific Sensititre ARIS HiQ System	K191918	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL	K152774	FDA 510(k)	Class II	Active
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL	K183324	FDA 510(k)	Class II	Active
Urea/Bun, Scal, Nortrol, Abtrol	K073295	FDA 510(k)	Class II	Active
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL	K242905	FDA 510(k)	Class II	Active
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)	K230935	FDA 510(k)	Class II	Active
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL	K221198	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL	K250990	FDA 510(k)	Class II	Active
Xpect Flu A & B	K092423	FDA 510(k)	Class II	Active
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml	K192729	FDA 510(k)	Class II	Active
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL	K172274	FDA 510(k)	Class II	Active
Alkaline Phosphatase (ifcc) Plus, Ecal, Nortrol, Abtrol	K073191	EUDAMEDFDA 510(k)	Class II	Active
Uric Acid (aox), Scal, Nortrol, Abtrol	K073612	FDA 510(k)	Class II	Active
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.	K242843	FDA 510(k)	Class II	Active
Sensititre Susceptibility Plates	K141000	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL	K252014	FDA 510(k)	Class II	Active
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL	K173209	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL	K242653	FDA 510(k)	Class II	Active
Sensititre Susceptibility plates	K143288	FDA 510(k)	Class II	Active
Ast/Got (ifcc), Pyridoxal Phosphate, Ecal, Nortrol And Abtrol	K071580	EUDAMEDFDA 510(k)	Class II	Active
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml	K183033	FDA 510(k)	Class II	Active
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml	K193538	FDA 510(k)	Class II	Active
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL	K250575	FDA 510(k)	Class II	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Thermo Fisher Scientific has five recall records initiated between July 24, 2007, and September 23, 2010, all of which are recorded as terminated. The reasons cited include the need for additional system validation to confirm disinfection efficacy, a deviation in the concentration of Buffered Formalin Phosphate from specified limits, potential assay interference from endogenous ALT in patient samples, and reported issues with specimen integrity and premature chamber rotation stopping.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 23, 2010	Z-1735-2011	—	terminated	Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy.
Sep 23, 2010	Z-1734-2011	—	terminated	Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy.
Jun 3, 2009	Z-1320-2010	—	terminated	The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as well as complaints that the chamber may stop rotating prematurely, resulting in sample deterioration.
May 1, 2008	Z-2159-2008	—	terminated	Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.
Jul 24, 2007	Z-0015-2008	—	terminated	Method is susceptible to positive interference from endogenous ALT in patient samples.