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Ortho

FDA UDI

Class I (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 7% BSA (5 ML) FDA UDI
Model / Reference
6844285 FDA UDI
Description
Ortho 7% BSA (5 ML) FDA UDI

Identifiers

Catalog Number
6844285 FDA UDI
Primary DI / UDI-DI
10758750030743 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Bovine serum albumin (BSA) immunohaematology reagent IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 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 I — 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 85621301-1bea-4dad-9081-0539c61c6bcb 35 fields · synced Jun 8, 2026