VP1 VP2 are reagents associated to API 20 E™ (20 100/20 160), RapiD 20 E™ (20 701), API® Staph (20 500), API® 20 Strep (20 600)

VP1 VP2 are reagents associated to API 20 E™ (20 100/20 160), RapiD 20 E™ (20 701), API® Staph (20 500), API® 20 Strep (20 600)
VP 1 + VP 2 - 70422

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of oxidase negative, gram negative bacteria belonging to the Enterobacteriaceae family, that have been isolated by culture from a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JTO

Device Name: Discs, Strips And Reagents, Microorganism Differentiation

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.2660

Third Party Flag: N

Medical Specialty: MI

Device Id: 03573026099626

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