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43 devices found
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Manufacturer: Nanosphere, Inc.
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Class
Enteric Pathogens (EP) Amplification Tray 20-011-023
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Enteric Pathogens (EP) Extraction Tray 20-009-023
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Respiratory Virus Plus (RV+) Extraction Tray 20-009-020
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Clostridium difficile (CDF) Nucleic Acid Test Cartridge 20-006-022
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Respiratory Virus Plus (RV+) Amplification Tray 20-011-020
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Gram-Negative Blood Culture (BC-GN) Extraction Tray 20-009-021
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Enteric Pathogens (EP) Stool Sample Preparation Kit 30-002-023
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Verigene® Reader (Refurbished) 10-0000-02R
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge 20-006-021
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge 20-006-018
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge 20-006-001
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Verigene® Reader 10-0000-02
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Clostridium difficile (CDF) Amplification Tray 20-011-022
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Enteric Pathogens (EP) Nucleic Acid Test Cartridge 20-006-023
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Gram-Positive Blood Culture (BC-GP) Utility Tray 20-011-018
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Respiratory Pathogens Flex (RP Flex) Amplification Tray 20-011-024
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Verigene® Processor SP 10-0000-07
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Gram-Negative Blood Culture (BC-GN) Utility Tray 20-011-021
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge 20-006-024
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
Clostridium difficile (CDF) Stool Sample Preparation Kit 30-002-022
Nanosphere, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
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