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Alsevers Solution

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Medical Diagnostics GmbH

Identity

Trade Name
Alsevers Solution FDA UDI
Generic Name
Cell preservation/storage/dilution solution IVD FDA UDI
Device Name
Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods FDA UDI
Model / Reference
806510100 FDA UDI
Description
Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods FDA UDI

Identifiers

Catalog Number
806510100 FDA UDI
Primary DI / UDI-DI
07611969951369 FDA UDI
FDA Product Code
KSZ FDA UDI
GMDN Term
Cell preservation/storage/dilution solution IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9175 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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: Cell preservation/storage/dilution solution IVD

Alsevers Solution by Bio-Rad Medical Diagnostics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cell preservation/storage/dilution solution IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Medical Diagnostics GmbH

Sources (1)

  • FDA UDI fa261f40-2095-4d1a-b856-80d4138c3143 36 fields · synced Jun 8, 2026