115 results · 7ms · Sources: EU EUDAMED, US FDA

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β-CTX CLIA Microparticles

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·2 devices

CTX-M β-lactamases Rapid Test

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EU IVDD · Eu Ivd General ·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device

IDS Beta CrossLaps® (CTX-I)

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EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·3 devices

IDS-iSYS CTX-I (CrossLaps®)

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EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·2 devices

Urine CartiLaps® (CTX-II) EIA

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EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

Alpha CrossLaps® (CTX-I) ELISA

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EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

Urine CrossLaps® (CTX-I) EIA

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EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

Serum CrossLaps® (CTX-I) ELISA

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EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

Urine BETA CrossLaps® (CTX-I) ELISA

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EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

Vibrio Cholera (Gene CTX)Real Time PCR Kit

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EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Vibrio Cholera CTX Gene/O1/O139 Real Time PCR Kit

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EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Buffers (Unassignable ), Supplem. Reagents, etc

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EU IVDR · Eu Ivd Class A ·AusDiagnostics Pty Ltd·1 device

PlexPCR RespiVirus

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EU IVDR · Eu Ivd Class B ·SpeeDx Pty. Ltd.·3 devices

Step 2 Plates for Atypical Pneumonia 8-well

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EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Urinogenital (8-well)

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EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Pneumonia (16-well)

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EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Viral CSF (8-well)

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EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Urinogenital and Resistance 12-well

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EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for STI (16-well)

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EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device

Step 2 Plates for Herpes, Enterovirus and Adenovirus 8-well

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EU IVDD · Eu Ivd Annex 2 List B ·AusDiagnostics Pty Ltd·1 device