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BIOARRAY SOLUTIONS LTD

United States·US-MF-000022068

Last updated May 24, 2026

What BIOARRAY SOLUTIONS LTD makes

BioArray Solutions Ltd manufactures in vitro diagnostic (IVD) reagents, controls, and instruments for blood group genotyping, including filled vials for enzymes like Lambda Exonuclease and HotStarTaq DNA Polymerase, as well as bead-based test kits and molecular beadchip assays for human erythrocyte antigen detection. Their portfolio also includes semi-automated microarray analysers, such as the BioArray Assay Imaging System (AIS) series, designed for laboratory use in blood typing and genetic analysis. Additional products encompass performance standards, calibrators, and controls for optical laboratory instruments, ensuring precision in diagnostic workflows.

The company’s devices are regulated under multiple classifications, including Class A, Class C, Class II, and Class III, reflecting varying levels of risk and oversight. Their products are listed in regulatory databases such as EUDAMED, FDA’s 510(k) premarket notification submissions, and the FDA’s Unique Device Identifier (UDI) registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 35, Technology Drive, Warren, United States
Website: www.werfen.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jesdeep Sidhu
EUDAMED SRN: US-MF-000022068
FDA FEI Number: —
DUNS Number: 949103725

Catalogue (24)

Device	Model / Reference	Registries	Class	Status
Filled Vial, Lambda Exonuclease	800-00195	FDA UDI	Class III	Active
Precise TypeTM HEA BeadCheck Kit	800-20236	FDA UDI	Class II	Active
BeadCheck HEA Ref-pA, Bulk and Fill	800-00228	FDA UDI	Class II	Active
BioArray Assay Imaging System TM (AIS) 400D	790-20016-RF	FDA UDI	Class II	Active
Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides	800-20202-08	FDA UDI	Class III	Active
Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate	800-20202-96	FDA UDI	Class III	Active
Filled Vial, Negative Control 1mL	800-00287	FDA UDI	Class III	Active
BioArray Assay Imaging System TM (AIS) 400C	790-20006-RF	FDA UDI	Class II	Active
Filled Vial, HotStarTaq DNA Polymerase	800-10242	FDA UDI	Class III	Active
Filled Vial, eMAPTM Elongation Mix	800-00193	FDA UDI	Class III	Active
BioArray Assay Imaging SystemTM (AIS) 400C	790-20006	FDA UDI	Class II	Active
Carrier Box, ETC, Slide, IVD	800-20301	FDA UDI	Class II	Active
Filled Vial, Clean-up, 330uL	800-00191	FDA UDI	Class III	Active
BeadCheck HEA Ref-pB, Bulk and Fill	800-00229	FDA UDI	Class II	Active
Filled Vial, HEA 1.2 PCR Mix	800-00194	FDA UDI	Class III	Active
MIA FORA NGS MFlex 6 HLA Typing Kit, 96 test	SR-800-10535-96	EUDAMED	Class C	Active
MIA FORA NGS MFlex 11 HT HLA Typing Kit	SR-800-10534-1152	EUDAMED	Class C	Active
Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400	K043067	FDA 510(k)	Class II	Active
BioArray Array Imaging System TM (AIS) 400D	790-20016	EUDAMEDFDA UDI	Class A	Active
MIA FORA NGS MFlex 6 HT HLA Typing Kit	SR-800-10535-1152	EUDAMED	Class C	Active
MIA FORA NGS Software (LINUX)	SR-850-00043	EUDAMED	Class C	Active
MIA FORA NGS MFlex 11 HLA Typing Kit, 96 test	SR-800-10534-96	EUDAMED	Class C	Active
MIA FORA NGS MFlex 6 HLA Typing Kit, 24 test	SR-800-10535-24	EUDAMED	Class C	Active
MIA FORA NGS MFlex 11 HLA Typing Kit, 24 test	SR-800-10534-24	EUDAMED	Class C	Active

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IMMUCOR Medizinische Diagnostik GmbH DE

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