gudid Primary ID: 701261

QUANTA Flash Ro52 Calibrators (UDI 701261)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The QUANTA Flash Ro52 Calibrators (Model/Catalog Number: 701261) is a medical device manufactured by INOVA DIAGNOSTICS, INC.. This product is indexed under FDA Product Code / Category Classification JIT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 701261
Product Code / EMDN: JIT
Device Name: 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. 2. QUANTA Flash Ro52 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives.
Database Sync Date: 2026-08-09 09:10:49

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of QUANTA Flash Ro52 Calibrators?

The registered manufacturer of record for QUANTA Flash Ro52 Calibrators is INOVA DIAGNOSTICS, INC..

What is the Primary UDI-DI identifier for QUANTA Flash Ro52 Calibrators?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 701261.

What classification code is assigned to this device?

This device is registered under product classification code JIT.

Similar Classification Devices (JIT)

Other Devices by INOVA DIAGNOSTICS, INC.

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