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Ortho

FDA UDI

Class II (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
ORTHO FDA UDI
Generic Name
Immunoglobulin-sensitized reagent red blood cell IVD, control FDA UDI
Device Name
Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control FDA UDI
Model / Reference
719810 FDA UDI
Description
Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control FDA UDI

Identifiers

Catalog Number
719810 FDA UDI
Primary DI / UDI-DI
10758750004072 FDA UDI
FDA Product Code
KSF FDA UDI
GMDN Term
Immunoglobulin-sensitized reagent red blood cell IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9650 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

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Immunoglobulin-sensitized reagent red blood cell IVD, control

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

Similar devices

Also classified as Immunoglobulin-sensitized reagent red blood cell IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho-Clinical Diagnostics

Sources (1)

  • FDA UDI d46d20c7-3cf8-45d5-ae7e-82a412381593 35 fields · synced May 30, 2026