Ortho

FDA UDI

Class II (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name: ORTHO FDA UDI
Generic Name: Gel column agglutination centrifuge IVD FDA UDI
Device Name: ORTHO™ Workstation ID-MTS Gel FDA UDI
Model / Reference: 6904630 FDA UDI
Description: ORTHO™ Workstation ID-MTS Gel FDA UDI

Identifiers

Catalog Number: 6904630 FDA UDI
Primary DI / UDI-DI: 10758750030149 FDA UDI
FDA Product Code: KSN FDA UDI
GMDN Term: Gel column agglutination centrifuge IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9285 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gel column agglutination centrifuge IVD

Ortho by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Gel column agglutination centrifuge IVD.

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LT Medical Centrifuge for Blood Grouping Card — Zhuhai Longtime Biological Technology Co., Ltd · Class I
LT Medical Centrifuge for Blood Grouping Card — Zhuhai Longtime Biological Technology Co., Ltd · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ortho-Clinical Diagnostics

Sources (1)

FDA UDI 4bf6efd8-b523-49a4-a4d9-e97781613ae4 35 fields · synced Jun 8, 2026