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Sign in to claim this brandTrek Diagnostic Systems, Inc.
US
Last updated May 23, 2026
Information
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- US
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Catalogue (139)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sensititre | CMC3VGNF | FDA UDI | Class II | Active |
| Sensititre | CMC4NUWF | FDA UDI | Class II | Active |
| Sensititre | CMC3NUWF | FDA UDI | Class II | Active |
| Sensititre | MDRGN3F | FDA UDI | Class II | Unknown |
| Sensititre | GNID | FDA UDI | Class I | Active |
| Sensititre | GNUR3F | FDA UDI | Class II | Unknown |
| Sensititre | GPALL2F | FDA UDI | Class II | Active |
| Sensititre | CMC2VGPF | FDA UDI | Class II | Active |
| Sensititre | GN2F | FDA UDI | Class II | Unknown |
| Sensititre | YO4IVD | FDA UDI | Class II | Active |
| Sensititre | CMC1ANYF | FDA UDI | Class II | Active |
| Sensititre | CMC3ANYF | FDA UDI | Class II | Active |
| Sensititre | FDANDPF | FDA UDI | Class II | Active |
| Sensititre | CMC1GPUF | FDA UDI | Class II | Active |
| Sensititre | CMT1DGPF | FDA UDI | Class II | Active |
| Sensititre | STP6F | FDA UDI | Class II | Unknown |
| Sensititre | CMC1DLOR | FDA UDI | Class II | Active |
| Sensititre | CMC6AFLF | FDA UDI | Class II | Active |
| Sensititre | MDRGN2F | FDA UDI | Class II | Active |
| Sensititre | CMC6VGNF | FDA UDI | Class II | Active |
| Sensititre | GPN3F | FDA UDI | Class II | Active |
| Sensititre | CMC7AFLF | FDA UDI | Class II | Active |
| Sensititre | CMC2PUWF | FDA UDI | Class II | Active |
| Sensititre | CMC1CCHF | FDA UDI | Class II | Active |
| Sensititre | CMC1OUNF | FDA UDI | Class II | Active |
| Sensititre | CMC3AFLF | FDA UDI | Class II | Active |
| Sensititre | GN4F | FDA UDI | Class II | Unknown |
| Sensititre | YO2IVD | FDA UDI | Class II | Unknown |
| Healing Healthcare Pro | Revision 2 | FDA UDI | Class II | Active |
| Sensititre | GPALL1F | FDA UDI | Class II | Unknown |
| Sensititre | HPB2 | FDA UDI | Class II | Active |
| Sensititre | CMC9ARUP | FDA UDI | Class II | Active |
| Sensititre | ESB1F | FDA UDI | Class II | Unknown |
| Sensititre | CMC1MDNF | FDA UDI | Class II | Active |
| Sensititre | CMC4VGPF | FDA UDI | Class II | Active |
| Sensititre | YO3IVD | FDA UDI | Class II | Unknown |
| Sensititre | STP7F | FDA UDI | Class II | Unknown |
| Sensititre | CMC1GNCC | FDA UDI | Class II | Active |
| Sensititre | OMADFAST | FDA UDI | Class II | Active |
| Sensititre | CMT1DSTF | FDA UDI | Class II | Active |
| Sensititre | GN3F | FDA UDI | Class II | Unknown |
| Sensititre | ARUP1MDF | FDA UDI | Class II | Active |
| Sensititre | GN7F | FDA UDI | Class II | Active |
| Sensititre | GPALL3F | FDA UDI | Class II | Active |
| Sensititre | GNUR2F | FDA UDI | Class II | Active |
| Sensititre | CMC1AXPF | FDA UDI | Class II | Active |
| Sensititre | CBC3URNF | FDA UDI | Class II | Active |
| Sensititre | FDANDSF | FDA UDI | Class II | Active |
| Sensititre | CMC5VGNF | FDA UDI | Class II | Active |
| Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST | V4000 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
Not available yet.
Authorities
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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 |
|---|---|---|---|---|
| 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