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Diagnostic Automation

FDA UDI

Class I (US FDA UDI)

by Diagnostic Automation, Inc.

Identity

Trade Name
Diagnostic Automation FDA UDI
Generic Name
Microplate reader IVD, automated/semi-automated FDA UDI
Device Name
DA800TS Microplate Reader is an affordable, high-quality microplate reader for assays in 6- to 96-well formats. The color touchscreen provides a visual user interface, making programming simple. The onboard software includes “quick read” and custom protocols, with data viewed immediately after measure, followed by export to USB or to the compact printer. FDA UDI
Model / Reference
DAR800TS FDA UDI
Description
DA800TS Microplate Reader is an affordable, high-quality microplate reader for assays in 6- to 96-well formats. The color touchscreen provides a visual user interface, making programming simple. The onboard software includes “quick read” and custom protocols, with data viewed immediately after measure, followed by export to USB or to the compact printer. FDA UDI

Identifiers

Catalog Number
DAR800TS FDA UDI
Primary DI / UDI-DI
00894175000480 FDA UDI
FDA Product Code
JJQ FDA UDI
GMDN Term
Microplate reader IVD, automated/semi-automated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2300 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microplate reader IVD, automated/semi-automated

Diagnostic Automation by Diagnostic Automation, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microplate reader IVD, automated/semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 0122c21a-339f-46d5-ad17-960be771d03d 35 fields · synced May 31, 2026