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Note: 1. All the test reports submitted as a part of the dossier should be signed and date...

2023-10-05T05:40:02

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Note: 1. All reports submitted as a part of the dossier should be signed and dated by the ...

2023-09-16T04:57:03

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(B) Such summary information may include: (i) declaration or certificate of conformity to ...

2023-09-14T05:11:45

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This summary may include: (a) Where a recognized standard exists, a declaration/certificat...

2023-10-03T05:13:09

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9.2 Reproducibility: This section should include reproducibility estimates and information...

2023-10-04T04:23:16

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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

2023-10-03T05:22:30

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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

2023-10-03T05:16:56

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1.1 Introductory descriptive information on the in vitro diagnostic medical device, the in...

2023-09-16T05:04:26

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PROVIDED that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or Bovi...

2023-09-16T04:48:49

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