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QBC Diagnostics

FDA UDI

Class II (US FDA UDI)

by Drucker Diagnostics

Identity

Trade Name
QBC Diagnostics FDA UDI
Generic Name
Microscope light source FDA UDI
Device Name
ParaLens Advance with 40X & 100X Objectives FDA UDI
Model / Reference
424346 FDA UDI
Description
ParaLens Advance with 40X & 100X Objectives FDA UDI

Identifiers

Catalog Number
424346 FDA UDI
Primary DI / UDI-DI
00858092006314 FDA UDI
510(k) Number
K891276 FDA UDI
FDA Product Code
GKZ FDA UDI
GMDN Term
Microscope light source FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Microscope light source

QBC Diagnostics by Drucker Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microscope light source.

Cleared under the same submission

K891276 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drucker Diagnostics

Sources (1)

  • FDA UDI fad446fa-94cc-49bf-8862-0f60cd2d15c1 35 fields · synced Jun 6, 2026