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ALBAhance LISS Additive Reagent

FDA UDI

Class II (US FDA UDI)

by Alba Bioscience Limited

Identity

Trade Name
ALBAhance LISS Additive Reagent FDA UDI
Generic Name
Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
Device Name
ALBAhance LISS Additive Reagent. FDA UDI
Model / Reference
Z333U FDA UDI
Description
ALBAhance LISS Additive Reagent. FDA UDI

Identifiers

Primary DI / UDI-DI
05060242471544 FDA UDI
FDA Product Code
KSK FDA UDI
GMDN Term
Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9400 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: Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

ALBAhance LISS Additive Reagent by Alba Bioscience Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Low ionic-strength salt solution (LISS) immunohaematology reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alba Bioscience Limited

Sources (1)

  • FDA UDI 40b4435b-df5e-42a4-808c-68b2f48c80ef 34 fields · synced Jun 8, 2026