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» Microbiology Devices: Classification of In Vitro Diagnostic Device for Bacillus Species Detection
Microbiology Devices: Classification of In Vitro Diagnostic Device for Bacillus Species Detection
Document ID:
FDA-2011-N-0103-0001
Document Type:
Proposed Rule
Agency:
Food And Drug Administration
Topics:
Biologics, Laboratories, Medical Devices
Federal Register Number:
2011-12088
CFR Citation:
21 CFR Part 866
View Document:
Details Information
Document Subtype:
NPR-Notice of Proposed Rule-Making
Received Date:
May 17 2011, at 12:00 AM Eastern Daylight Time
Start-End Page:
28689 - 28696
Page Count:
8
Comment Start Date:
May 18 2011, at 12:00 AM Eastern Standard Time
Comment Due Date:
August 16 2011, at 11:59 PM Eastern Standard Time
Comments
Total:
1
BARDA/ASPR - Comment
Posted:
09/29/2011
ID:
FDA-2011-N-0103-0007
Comment Period Closed
Aug 16,2011 11:59 PM ET
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Total:
12
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens
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Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents
Medical Devices: Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
Microbiology Devices: Classification of In Vitro Diagnostic Device for Yersinia Species Detection
Immunology and Microbiology Devices: Reclassification of the Herpes Simplex Virus Serological Assay Device
Draft Guidance for Industry and Staff; Availability: In Vitro Diagnostic Devices for Bacillus Species Detection
Medical Devices; Immunology and Microbiology Devices: Classification of Ovarian Adnexal Mass Assessment Score Test System
Medical Devices Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
Immunology and Microbiology Devices: Reclassification of Herpes Simplex Virus Serological Assay Device
Microbiology Devices: Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays; Confirmation of Effective Date
Microbiology Devices: Classification of In Vitro Diagnostic Device for Bacillus Species Detection
Details Information
Comments
Posted: 09/29/2011 ID: FDA-2011-N-0103-0007
Aug 16,2011 11:59 PM ET
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