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Trek Diagnostic Systems, Inc.

US

Last updated May 23, 2026

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (139)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K062722
FDA 510(k)
Class IIActive
Sensititre 18-24hr Susceptibility Plates K093865
FDA 510(k)
Class IIActive
Sensititre Yeastone Susceptibility Plates- Additional Antimicrobics K081063
FDA 510(k)
Class IIActive
Gatifloxin K020762
FDA 510(k)
Class IIActive
Sensititre 18 - 24 Hour Susceptibility Plate K073653
FDA 510(k)
Class IIActive
Cefotaxime K020859
FDA 510(k)
Class IIActive
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plates K032382
FDA 510(k)
Class IIActive
Sensititre 18-24 Hours Susceptibility Plates (gatifloxacin) K001035
FDA 510(k)
Class IIActive
Modification To Sensititre Yeastone Mic Susceptibility Test K991810
FDA 510(k)
Class IIActive
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K013075
FDA 510(k)
Class IIActive
Haemophilus/Streptococcus Pneumoniae K021339
FDA 510(k)
Class IIActive
Sensititre 18-24 Hours Susceptibility Plates K022656
FDA 510(k)
Class IIActive
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K021997
FDA 510(k)
Class IIActive
Haemophilus/Streptococcus Pneumoniae (hp)mic Susceptibility Plates K013195
FDA 510(k)
Class IIActive
Sensititre 18-24 Hr Susceptibility Plates(addition Of Meropenem) K983244
FDA 510(k)
Class IActive
Sensititre 18-24 Hour Susceptibility Plate K031545
FDA 510(k)
Class IIActive
Sensititre 18-24 Hour Suseceptibility Plates K083606
FDA 510(k)
Class IIActive
Sensititre 18-24 Hr Susceptibility Plates K111615
FDA 510(k)
Class IIActive
Autoreader 2 K103532
FDA 510(k)
Class IIActive
Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K013368
FDA 510(k)
Class IIActive
Sensititre Yeastone Susceptibility Plates K133038
FDA 510(k)
Class IIActive
Sensititre 18 - 24 Hours Susceptibility Plates K011803
FDA 510(k)
Class IIActive
Modification To Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K062839
FDA 510(k)
Class IIActive
Sensititre Susceptibility Plates-Additional Antimicrobics K003834
FDA 510(k)
Class IIActive
Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K012151
FDA 510(k)
Class IIActive
Sensititre Haemophilus / Streptococcus Pneumoniae (hp) Mic Plates K062190
FDA 510(k)
Class IIActive
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K012565
FDA 510(k)
Class IIActive
Sensititre 18-24 Hours Susceptibility Plates K024353
FDA 510(k)
Class IIActive
Sensititre 18-24 Hours Susceptibility Plates K022775
FDA 510(k)
Class IIActive
Sensititre 18-24 Hours Susceptibility Plates (quinupristin/Dalfopristin) K001558
FDA 510(k)
Class IIActive
Sensitire Susceptibility Plates- Additional Antimicrobics K052091
FDA 510(k)
Class IIActive
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K014258
FDA 510(k)
Class IIActive
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K021627
FDA 510(k)
Class IIActive
Versatrek Myco Pza Kit K052323
FDA 510(k)
Class IIActive
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate K012921
FDA 510(k)
Class IIActive
The Sensititre Aim K103456
FDA 510(k)
Class IIActive
Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Susceptibility Plate K013580
FDA 510(k)
Class IIActive
Hearing Healthcare Pro K171038
FDA 510(k)
Class IIActive
Sensititre N50531
FDA PMA
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Jul 23, 2012Z-2323-2012—terminated

Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test result inadvertently reverted to a negative result in the instrument database.

Jun 4, 2009Z-2324-2009—terminated

Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.

Sep 22, 2008Z-0669-2009—terminated

Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.

Aug 8, 2005Z-1540-05—terminated

Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.

Mar 4, 2005Z-0708-05—terminated

Blood culture bottles with an error in the bar code on the labels, were shipped.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Trek Diagnostic Systems Ltd GB