ALBA BIOSCIENCE LIMITED

FDA Device Registration & Listing · PENICUIK Midlothian, GB · Registration 3011683976

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011683976
FEI Number
3011683976
Entity Name
ALBA BIOSCIENCE LIMITED
City/State/Country
PENICUIK Midlothian, GB
Establishment Address
5 JAMES HAMILTON WAY, MILTON BRIDGE, PENICUIK Midlothian EH26 0BF, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ALBA BIOSCIENCE LIMITED (Owner Number: 9107181)
Owner / Operator Contact Address
5 JAMES HAMILTON WAY, MILTON BRIDGE, PENICUIK, GB-MLN EH26 0BF, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK080051
PMA Number
N/A

All Registered Proprietary Names

Ortho™ Confidence Manual System ALBAhance™ Bovine Serum Albumin 22% (Z305U) ALBAhance™ PEG (Z312U) ALBAhance™ LISS Additive (Z333U) ALBAlect Anti-A1 Lectin Ortho® Elution Kit ALBAcheck-BGS IgG Sensitized Red Cells Alba Elution Kit FETALSCREEN II

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2020-02-05
KSK Solution, Stabilized Enzyme Hematology Class 2 864.9400 2014-12-09
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2015-08-06
KSG Media, Potentiating For In Vitro Diagnostic Use Hematology Class 2 864.9600 2010-09-23
KSI Lectins And Protectins Hematology Class 2 864.9550 2011-12-30
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2019-04-12
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2025-11-19
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2010-12-29
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2025-11-19
KSK Solution, Stabilized Enzyme Hematology Class 2 864.9400 2016-04-15
MTI Kit, Cell Screening, Fetal Unknown Class N N/A 2009-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

Michelle Lalicata Business: ALBA BIOSCIENCE INC. Email: michelle.lalicata@alivedx.com Phone: (321) 4028306

Related Public Records

Same Entity

ALBA BIOSCIENCE LIMITED
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011683976. Last updated year: 2026. Please use registration number 3011683976 when referencing this establishment in official correspondence.
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