RAPIDEC® CARBA NP is a phenotypic test for rapid detection and confirmation of carbapenemase enzyme presence in Enterobacteriaceae and Pseudomonas aeruginosa isolated colonies
RAPIDEC® CARBA NP - RAPIDEC® CARBA NP
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative detection of cabapenemase enzyme production by a microorganism isolated from a clinical specimen by culture, using a chromogenic method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PTJ
Device Name: Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Device Class: 2
Physical State: Single use, disposable
Definition: Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Biochemical hydrolysis
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Not applicable
Regulation Number: 866.1640
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 03573026464387
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