IVD reagent kit containing 30 tests.

IVD reagent kit containing 30 tests.
BioFire® Blood Culture Identification 2 (BCID2) Panel - RFIT-ASY-0147

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry method.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PAM

Device Name: Gram-Positive Bacteria And Their Resistance Markers

Device Class: 2

Physical State: blood

Definition: A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Multiplexed DNA hybridization array

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Systemic

Regulation Number: 866.3365

Third Party Flag: N

Medical Specialty: MI

Code: PEO

Device Name: Fungal Organisms, Nucleic Acid-Based Assay

Device Class: 2

Physical State: Reagent Kit

Definition: A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Multiplexed nucleic acid-based assay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3365

Third Party Flag: N

Medical Specialty: MI

Code: PEN

Device Name: Gram-Negative Bacteria And Associated Resistance Markers

Device Class: 2

Physical State: Reagent kit

Definition: A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Multiplexed nucleic acid-based assay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3365

Third Party Flag: N

Medical Specialty: MI

Device Id: 00815381020338

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A