- Physicians Office Resource

The Dengue Virus NS1 Ag ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum.
Dengue Virus NS1 Ag ELISA - EIA-6090

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Dengue virus in a clinical specimen, using an enzyme immunoassay (EIA) 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: QCU

Device Name: Dengue Virus Antigen Assay

Device Class: 2

Physical State: ELISA Kit including different components, i.e., ELISA plates coated with antibodies, other capture antibodies, positive and negative controls etc.

Definition: Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Immunoassay e.g., ELISA

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human serum or plasma or whole blood or body fluid collected from patient

Regulation Number: 866.3945

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 00840239060907

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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