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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

Storage Environment Temperature - Degrees Celsius

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 Identifiers

Device 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

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