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Thermo Fisher Scientific

Last updated May 23, 2026

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Country: US
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Catalogue (81)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Cascadion™ SM 25-Hydroxy Vitamin D Control 3	NONE	FDA UDI	Class II	Unknown
Storage	1	FDA UDI	Class I	Active
Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set	NONE	FDA UDI	Class II	Unknown
Recapper, 110V, TCA	1	FDA UDI	Class I	Active
Indiko Plus	864	FDA UDI	Class I	Active
Cascadion™ SM 25-Hydroxy Vitamin D Control 2	NONE	FDA UDI	Class II	Active
Cascadion™ SM 25-Hydroxy Vitamin D Control 1	NONE	FDA UDI	Class II	Active
Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard	NONE	FDA UDI	Class II	Active
Indiko	863	FDA UDI	Class I	Active
Interface, TCA ImmunoCap 1000	1	FDA UDI	Class I	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL	K252062	FDA 510(k)	Class II	Active
Sensititre Susceptibility Plates	K143381	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL	K243169	FDA 510(k)	Class II	Active
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)	K150556	FDA 510(k)	Class II	Active
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL	K231433	FDA 510(k)	Class II	Active
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL	K192250	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 ug/ml	K203741	FDA 510(k)	Class II	Active
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL	K243738	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL	K171870	FDA 510(k)	Class II	Active
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)	K150236	FDA 510(k)	Class II	Active
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL	K182797	FDA 510(k)	Class II	Active
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.	K240445	FDA 510(k)	Class II	Active
Sensititre Haemophilus / Streptococcus Pneumoniae (hp) Susceptibility Plates	K133847	FDA 510(k)	Class II	Active
Thermo Scientific Sensititre ARIS HiQ System	K191914	FDA 510(k)	Class II	Active
Immunocap Allergen K82	K121463	FDA 510(k)	Class II	Active
Sensititre 18-24 Hour Mic Suceptibility System	K133773	FDA 510(k)	Class II	Active
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.	K241967	FDA 510(k)	Class II	Active
Sensititre Susceptibility Plates	K141651	FDA 510(k)	Class II	Active
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)	K143526	FDA 510(k)	Class II	Active
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)	K223844	FDA 510(k)	Class II	Active
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.	K242021	FDA 510(k)	Class II	Active
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL	K231994	FDA 510(k)	Class II	Active
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml	K231988	FDA 510(k)	Class II	Active
Dri Methadone Metabolite (100/300) Assay, Calibrators And Controls	K081378	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL	K242658	FDA 510(k)	Class II	Active
Qms Lidocaine	K090282	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL	K242659	FDA 510(k)	Class II	Active
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL	K181946	FDA 510(k)	Class II	Active
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml	K221899	FDA 510(k)	Class II	Active
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml	K232310	FDA 510(k)	Class II	Active
Mas Tox Control	K080085	FDA 510(k)	Class I	Active
Carbon Dioxide (co2), Scal, Nortrol And Abtrol	K071340	FDA 510(k)	Class II	Active
Amylase Eps Reagent	K070064	FDA 510(k)	Class II	Active
Spectra Mrsa	K073027	FDA 510(k)	Class II	Active
Sensititre Haemophilus/Streptococcus Pneumoniae(hp) Susceptibility Plates	K140985	FDA 510(k)	Class II	Active
Sensititre 18-24 Hour Susceptibility Plates	K142151	FDA 510(k)	Class II	Active
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL	K242657	FDA 510(k)	Class II	Active
Ise Module And Bar Code Reader Addition For The Datapro Clinical Chemistry Analyzer	K070531	FDA 510(k)	Class II	Active
Remel Spectra Vre	K092819	FDA 510(k)	Class II	Active
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL	K243201	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.

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.