← Back to catalogue

Bovine Serum Albumin 22%

FDA UDI

Class II (US FDA UDI)

by Alba Bioscience Limited

Identity

Trade Name
Bovine Serum Albumin 22% FDA UDI
Generic Name
Bovine serum albumin (BSA) immunohaematology reagent IVD FDA UDI
Device Name
Bovine Serum Albumin 22%. FDA UDI
Model / Reference
Z305U FDA UDI
Description
Bovine Serum Albumin 22%. FDA UDI

Identifiers

Primary DI / UDI-DI
05060242471520 FDA UDI
FDA Product Code
KSG FDA UDI
GMDN Term
Bovine serum albumin (BSA) immunohaematology reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9600 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

Yes

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

Bovine Serum Albumin 22% by Alba Bioscience Limited — 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

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

Manufacturer

Manufacturer
Alba Bioscience Limited

Sources (1)

  • FDA UDI 1d96ee52-c0b9-465c-b701-cc97ae12ad65 34 fields · synced May 30, 2026