Is this your brand? Sign in to claim ownership.
Sign in to claim this brandTrek Diagnostic Systems, Inc.
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (139)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sensititre | CMC2AFLF | FDA UDI | Class II | Active |
| Sensititre | MDRGN4F | FDA UDI | Class II | Active |
| Sensititre | GPALL3F | FDA UDI | Class II | Active |
| Sensititre | CMC5VGPF | FDA UDI | Class II | Active |
| Sensititre | YO2IVD | FDA UDI | Class II | Unknown |
| Sensititre | CMC5MDOH | FDA UDI | Class II | Active |
| Sensititre | FDANDSF | FDA UDI | Class II | Unknown |
| Sensititre | CMC3VGPF | FDA UDI | Class II | Active |
| Sensititre | CMC5MDOH | FDA UDI | Class II | Active |
| Sensititre | CMC1YOGV | FDA UDI | Class II | Active |
| Sensititre | CMC1JFMD | FDA UDI | Class II | Active |
| Sensititre | NF | FDA UDI | Class II | Unknown |
| Sensititre | CMC2CCHF | FDA UDI | Class II | Active |
| Sensititre | CMC4ANYF | FDA UDI | Class II | Active |
| Sensititre | YO3IVD | FDA UDI | Class II | Unknown |
| Sensititre | MEROVAB | FDA UDI | Class II | Active |
| Sensititre | GNUR5F | FDA UDI | Class II | Unknown |
| Sensititre | FDANDPF | FDA UDI | Class II | Active |
| Sensititre | GPN3F | FDA UDI | Class II | Active |
| Sensititre | CMC2VGNF | FDA UDI | Class II | Active |
| Sensititre | CMC1GPVF | FDA UDI | Class II | Active |
| Sensititre | CMC1VAPF | FDA UDI | Class II | Active |
| Sensititre | GPID | FDA UDI | Class I | Active |
| Sensititre | CMC5ANYF | FDA UDI | Class II | Active |
| Sensititre | CMC3VGPF | FDA UDI | Class II | Active |
| Sensititre | ESB1F | FDA UDI | Class II | Unknown |
| Sensititre | CMC1OUPF | FDA UDI | Class II | Active |
| Sensititre 18-24 Hour Susceptibility Plates | K024357 | FDA 510(k) | Class II | Active |
| Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plates | K040619 | FDA 510(k) | Class II | Active |
| Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plates | K040846 | FDA 510(k) | Class II | Active |
| Hearing Healthcare Pro | K183201 | FDA 510(k) | Class II | Active |
| Susceptibility Test Panel | K004045 | FDA 510(k) | Class II | Active |
| Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic And Susceptibility Plates | K062841 | FDA 510(k) | Class II | Active |
| Sensititre 18-24 Susceptibility Plate | K073558 | FDA 510(k) | Class II | Active |
| Sensititre Yeastone Susceptibility Plates | K090968 | FDA 510(k) | Class II | Active |
| Esp Culture System Ii - Myco Susceptibility Testing | K972772 | FDA 510(k) | Class II | Active |
| Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Susceptibility Plates | K013925 | FDA 510(k) | Class II | Active |
| Susceptibility Test Plate For Vancomycin Vrsa Limitation Removal | K060783 | FDA 510(k) | Class II | Active |
| Sensititre 18-24 Hours Susceptibility Plates | K033522 | FDA 510(k) | Class II | Active |
| Sensititre 18-24 Hour Susceptibility Plates | K073424 | FDA 510(k) | Class II | Active |
| Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate | K062783 | FDA 510(k) | Class II | Active |
| Sensititre Heamophilus/Streptococcus Pneumoniae (hp) Mic Plate | K014259 | FDA 510(k) | Class II | Active |
| Sensititre 18-24 Hours Susceptibility Plates | K053243 | FDA 510(k) | Class II | Active |
| Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate | K062022 | FDA 510(k) | Class II | Active |
| Versatrek | K032306 | FDA 510(k) | Class I | Active |
| Sensititre 18-24 Hours Susceptibility Plates | K001573 | FDA 510(k) | Class II | Active |
| Sensititre Haemophilus/Streptococcus Pneumoniae (hp) Mic Plate | K062816 | FDA 510(k) | Class II | Active |
| Sensititre 18-24 Hours Susceptibility Plates (moxifloxacin) | K001036 | FDA 510(k) | Class II | Active |
| Sensititre Susceptibility Plates-Additional Antimicrobics | K003868 | FDA 510(k) | Class II | Active |
| Heamophilus/Streptococcus Pneumoniae | K012895 | FDA 510(k) | 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 (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 |
|---|---|---|---|---|
| Jul 23, 2012 | Z-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, 2009 | Z-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, 2008 | Z-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, 2005 | Z-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, 2005 | Z-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