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Vitros Immunodiagnostic Products Anti-Hbe Reagent Pack/Anti-Hbe Calibrator

FDA PMA

Class II (US FDA PMA)

PMA P100001

by Ortho-Clinical Diagnostics

Identity

Trade Name
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS FDA PMA
Generic Name
Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA

Identifiers

PMA Number
P100001 FDA PMA
FDA Product Code
SEI FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 866.3173 FDA PMA
Regulation Number
866.3173 FDA PMA
Advisory Committee
Microbiology FDA PMA
FDA Decision
APRL FDA PMA

The Vitros Immunodiagnostic Products Anti-HBE Reagent Pack, Anti-HBE Calibrator, and Anti-HBE Controls are in vitro diagnostic reagents designed for the qualitative detection of antibodies to hepatitis B e antigen (anti-HBE) in human serum. These products are intended for use on the Vitros ECI/ECIQ Immunodiagnostic Systems to aid in the assessment of hepatitis B virus (HBV) infection status in adult and pediatric patients (ages 2 to 21). The Anti-HBE Reagent Pack facilitates testing, while the Calibrator and Controls ensure system accuracy and performance monitoring.

The Anti-HBE Reagent Pack is supplied as a single-use reagent for qualitative detection, requiring calibration with the provided Anti-HBE Calibrator and performance verification via the Anti-HBE Controls. These components are intended for use in clinical microbiology laboratories and are not approved for monitoring HBV disease progression or therapeutic response. The device is authorized under an FDA Premarket Approval (PMA) and classified as a Class II medical device (FDA regulation 866.3173).

Frequently asked questions

What is the purpose of the Vitros Anti-HBE Reagent Pack?

The Vitros Anti-HBE Reagent Pack is designed for the qualitative detection of antibodies to hepatitis B e antigen in human serum from individuals with symptoms of chronic hepatitis or those who have recovered from HBV infection, using the Vitros ECI/ECIQ Immunodiagnostic Systems.

What components are included in this diagnostic product set?

The product set includes the Anti-HBE Reagent Pack for testing, the Anti-HBE Calibrator for system calibration, and Anti-HBE Controls for performance monitoring, all intended for use on the Vitros ECI/ECIQ Immunodiagnostic Systems.

Is this device suitable for monitoring HBV disease progression or therapy response?

No, the Vitros Anti-HBE test performance has not been established for monitoring HBV disease progression or therapy response; further assessment of HBV infection is required to define the specific disease state.

What age range is this diagnostic product intended for?

The Vitros Anti-HBE Reagent Pack is intended for use with serum samples from both adult and pediatric patients aged 2 to 21 years old who have symptoms of chronic hepatitis or have recovered from HBV infection.

How should the Anti-HBE Reagent Pack be used in laboratory testing?

The Anti-HBE Reagent Pack is supplied as a single-use reagent that requires calibration with the provided Anti-HBE Calibrator and performance verification via the Anti-HBE Controls to ensure system accuracy when used on the Vitros ECI/ECIQ Immunodiagnostic Systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF INSTRUCTIONS FOR USE aHBe - Food and Drug Administration, Vitros Immunodiagnostic Products Anti-hbe Reagent Pack/Anti-hbe ..., Vitros® ECiQ Anti-HBe Immunoassay Reagent - 100 Tests

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Ortho-Clinical Diagnostics

Sources (1)

  • FDA PMA P100001 24 fields · synced Oct 6, 2026