400 College Road East, Princeton, United States, 08540
Showing 1–20 of 146 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Instrument/analyser IVDs | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| I-STAT 1 9V NIMH BATTERY | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - 300-G I-STAT 1 ANALYZER (IMMUNO) | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - 6+ CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - BNP CARTRIDGE AND CONTROLS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - CELITE ACT CARTRIDGE AND CONTROLS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - CG4+ CARTRIDGE (LACTATE TEST) | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - CG8+ CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - CHEM8+ CARTRIDGE AND CONTROLS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - CK-MB CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - CREA CATRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - CTNI CARTRIDGE, CONTROLS AND CALIBRATORS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - E3+ CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - EC4+ CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - EC8+ CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - EG6+ CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - EG7+ CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - ELECTRONIC SIMULATOR | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| I-STAT 1 ANALYZER SYSTEM - G3+ CARTRIDGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
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