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Ortho

FDA UDI

Class II (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
ORTHO FDA UDI
Generic Name
Bovine serum albumin (BSA) immunohaematology reagent IVD FDA UDI
Device Name
ORTHO® Bovine Albumin Solution Polymerized Bovine Solution FDA UDI
Model / Reference
718300 FDA UDI
Description
ORTHO® Bovine Albumin Solution Polymerized Bovine Solution FDA UDI

Identifiers

Catalog Number
718300 FDA UDI
Primary DI / UDI-DI
10758750003723 FDA UDI
FDA Product Code
DCF FDA UDI
GMDN Term
Bovine serum albumin (BSA) immunohaematology reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5040 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: Bovine serum albumin (BSA) immunohaematology reagent IVD

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

Similar devices

Also classified as Bovine serum albumin (BSA) immunohaematology reagent IVD.

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 aa48b28d-178e-4157-b830-95b4dd5301e7 35 fields · synced Jun 8, 2026