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Product Classification / EMDN Category

FDA Product Code: W0105011203

Directory of devices assigned to product classification code W0105011203.

emdn_classification STAPHYLOCOCCAL DETECTION BY NA REAGENTS Manufacturer:
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eudamed_udi NATtrol™ Chlamydia trachomatis Positive Control Pack Manufacturer: ZeptoMetrix LLC
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eudamed_udi Step 2 Plates for Staphylococcus typing 8-well Manufacturer: AusDiagnostics Pty Ltd
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eudamed_udi Staphylococcus Aureus Real Time PCR Kit Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
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eudamed_udi Xpert® MRSA /SA SSTI Manufacturer: Cepheid AB
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eudamed_udi Rabbit Coagulase Plasma 30.0 ml Manufacturer: Pro-Lab Diagnostics UK
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eudamed_udi Methicillin-resistant Staphylococcus aureus mecA Gene Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.
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eudamed_udi Xpert® MRSA/SA Blood Culture Manufacturer: Cepheid AB
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eudamed_udi Xpert® SA Nasal Complete Manufacturer: Cepheid AB
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eudamed_udi Panther Fusion MRSA Assay Manufacturer: Hologic
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eudamed_udi CDX-30-05 Manufacturer: Abacus Diagnostica Oy
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eudamed_udi Sentosa SA Direct MRSA/SA PCR Test (4x24) Manufacturer: Vela Operations Singapore Pte. Ltd.
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eudamed_udi STANDARD™ M10 MRSA/SA Manufacturer: SD Biosensor Inc.
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eudamed_udi Step 1 tubes for Staphylococcus typing 8-well Manufacturer: AusDiagnostics Pty Ltd
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eudamed_udi Rabbit Coagulase Plasma 20.0 ml Manufacturer: Pro-Lab Diagnostics UK
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eudamed_udi GenoType MRSA VER 3.0 Manufacturer: Hain Lifescience GmbH
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eudamed_udi Staphylococcus Aureus and Methicillin-resistant Staphylococcus Aureus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) Manufacturer: RocGene (Xuzhou) Technology Limited
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eudamed_udi Rabbit Coagulase Plasma 10.0 ml Manufacturer: Pro-Lab Diagnostics UK
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eudamed_udi Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.
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eudamed_udi Rabbit Coagulase Plasma 10 x 3.0ml Manufacturer: Pro-Lab Diagnostics UK
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eudamed_udi NATtrol™ Chlamydia trachomatis Positive Control Pack Manufacturer: ZeptoMetrix LLC
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eudamed_udi Methicillin-resistant Staphylococcus aureus mecA Gene Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.
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eudamed_udi RIDA®GENE MRSA Manufacturer: R-Biopharm AG
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eudamed_udi CDX-30-05 Manufacturer: Abacus Diagnostica Oy
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eudamed_udi Staphylococcus Aureus and Methicillin-resistant Staphylococcus Aureus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) Manufacturer: RocGene (Xuzhou) Technology Limited
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eudamed_udi RIDA®Plex Staphylococcus Typing 8 well Manufacturer: AusDiagnostics Pty Ltd
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eudamed_udi FlashDetect™ LyocartE MRSA&SA Assay Manufacturer: Coyote Bioscience Co., Ltd.
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eudamed_udi CDX-30-05 Manufacturer: Uniogen Oy
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eudamed_udi Staphylococcus Aureus DNA Detection Kit (Fluorescence PCR Method)  Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
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eudamed_udi CDX-30-02 Manufacturer: Abacus Diagnostica Oy
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eudamed_udi FluoroType® MRSA VER 3.0 Manufacturer: Hain Lifescience GmbH
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eudamed_udi NATtrol™ Chlamydia trachomatis Positive Control Pack Manufacturer: ZeptoMetrix LLC
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eudamed_udi Vancomycin-Resistant Staphylococcus Aureus (VRSA) Real Time PCR Kit Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
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eudamed_udi CDX-30-02 Manufacturer: Uniogen Oy
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eudamed_udi FlashDetect™ LyocartE MRSA&SA Assay Manufacturer: Coyote Bioscience Co., Ltd.
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eudamed_udi Methicillin-resistant Staphylococcus Aureus (MRSA) Real Time PCR Kit Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
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eudamed_udi Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.
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eudamed_udi RIDA®Plex Staphylococcus Typing 8 well Manufacturer: AusDiagnostics Pty Ltd
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eudamed_udi CDX-30-05 Manufacturer: Uniogen Oy
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