Abbott RealTime ZIKA Control Kit

Abbott RealTime ZIKA Control Kit
RealTime - 09N27-080

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Zika virus in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: POA

Device Name: Reagents, Zika Virus Nucleic Acid

Device Class: N

Physical State: In Vitro Diagnostic Primers, Probes and/or capture oligonucleotides.

Definition: Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.

Submission Type ID: 8

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Nucleic acid amplification.

Life Sustain Support Flag: N

Unclassified Reason: 11

Implant Flag: N

Target Area: The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00884999046757

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