Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003834021

FEI Number

3002808039

Entity Name

RSR LTD.

City/State/Country

CARDIFF, GB

Establishment Address

Parc Ty Glas, Llanishen, CARDIFF CF14 5DU, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RSR Limited (Owner Number: 10023525)

Owner / Operator Contact Address

Parc Ty Glas, Llanishen, Cardiff, GB-CRF CF14 5DU, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080159

PMA Number

N/A

All Registered Proprietary Names

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT KRONUS ZINC TRANSPORTER 8 AUTOANTIBODY (ZnT8Ab) ELISA KIT KRONUS INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT ANTI-THYROGLOBULIN TEST KIT KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Steriod 21-Hydroxylase Antibody (21-OHAb) ELISA Kit KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT 125-I TSH RECEPTOR ANTIBODY KIT KONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay KRONUS IA-2 AUTOANTIBODY (IA-2Ab) ELISA KIT KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCN	Insulin Autoantibody Kit	Immunology	Class 2	866.5660	2007-11-29
NWG	Autoantibodies, Glutamic Acid Decarboxylase (Gad)	Immunology	Class 2	866.5660	2007-11-29
PHF	Zinc Transporter 8 Auto-Antibody	Immunology	Class 2	866.5670	2014-11-19
NST	Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking	Immunology	Class 2	866.5660	2007-11-29
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2007-11-29
OIF	Tyrosine Phosphatase (Ia-2) Autoantibody Assay	Immunology	Class 2	866.5660	2023-11-16
PCG	21-Hydroxylase Antibody (21-Ohab)	Immunology	Class 2	866.5660	2019-11-07
NWG	Autoantibodies, Glutamic Acid Decarboxylase (Gad)	Immunology	Class 2	866.5660	2007-11-29
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2007-11-29
PAF	Voltage Gated Calcium Channel (Vgcc) Antibody Assay	Immunology	Class 2	866.5660	2012-06-28
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2007-11-29
OIF	Tyrosine Phosphatase (Ia-2) Autoantibody Assay	Immunology	Class 2	866.5660	2008-11-10
PNI	Aquaporin-4 Autoantibody	Immunology	Class 2	866.5665	2016-11-08
OIF	Tyrosine Phosphatase (Ia-2) Autoantibody Assay	Immunology	Class 2	866.5660	2018-12-19
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2008-11-10

Official Correspondent

Jill Clark

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

RSR Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K000362	Zeus Scientific, Inc.	MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM	2000-02-18
K250250	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Anti-Thyroid Peroxidase II	2025-10-17
K152061	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material	2016-03-03

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3003559191	Tecan Trading AG	Maennedorf Zurich, CH
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003834021. Last updated year: 2026. Please use registration number 3003834021 when referencing this establishment in official correspondence.