VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

Gram-negative Bacteria And Associated Resistance Markers

NANOSPHERE, INC

The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Gram Negative Blood Culture Nucleic Acid Test (bc-gn).

Pre-market Notification Details

• Device ID: K132843
• 510k Number: K132843
• Device Name: VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
• Classification: Gram-negative Bacteria And Associated Resistance Markers
• Applicant: NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062
• Contact: Mark Del Vecchio
• Correspondent: Mark Del Vecchio; NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062
• Product Code: PEN
• CFR Regulation Number: 866.3365 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-10
• Decision Date: 2014-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857573006300	K132843	000
00857573006249	K132843	000
00857573006140	K132843	000