- Physicians Office Resource

Abbott RealTime ZIKA Amplification Reagent Kit
RealTime - 09N27-090

Device Description

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 qualitative and/or quantitative detection of nucleic acid from Zika virus in a clinical specimen.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

-15.00
-25.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00884999046771

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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