ICUBATE, INC

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrumentation For Clinical Multiplex Test Systems (NSU) (2) Gram-Negative Bacteria And Associated Resistance Markers (PEN) (1) Gram-Positive Bacteria And Their Resistance Markers (PAM) (1)

Premarket Exempt

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iC-GPC Assay - B769ICCAAJA00000 Catalog Number :

Device Description : The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multip The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci.

Device Class : 2

Duns Number: 830140377

Premarket Exempt : No

Product Code : PAM

Prescription Use : Yes

Device Count : 1

iC-GN Assay - B769ICCAAQA00000 Catalog Number :

Device Description : The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multipl The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli.

Device Class : 2

Duns Number: 830140377

Premarket Exempt : No

Product Code : PEN

Prescription Use : Yes

Device Count : 1

iC-Processor - B769ICPADAAA0000 Catalog Number :

Device Description : The iC-System is an in vitro diagnostic device designed to perform multiplex amp The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.

Device Class : 2

Duns Number: 830140377

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

iC-Reader - B769ICRADAA00000 Catalog Number :

Device Class : 2

Duns Number: 830140377

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

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