← Back to catalogue

Ortho

FDA UDI

Class N (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
ORTHO FDA UDI
Generic Name
Microplate reader IVD, automated/semi-automated FDA UDI
Device Name
Auto Reader IV FDA UDI
Model / Reference
6902093 FDA UDI
Description
Auto Reader IV FDA UDI

Identifiers

Catalog Number
6902093 FDA UDI
Primary DI / UDI-DI
10758750007523 FDA UDI
FDA Product Code
MZA FDA UDI
GMDN Term
Microplate reader IVD, automated/semi-automated FDA UDI

Classification

Device Class
N 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

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

Ortho by Ortho-Clinical Diagnostics — Class N — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ortho-Clinical Diagnostics

Sources (1)

  • FDA UDI 41d21524-3f9e-4acc-83dd-edf0366e7d06 35 fields · synced May 30, 2026