FDA Registration
Active
🇬🇧 United Kingdom
RSR LTD.
Reg #: 3003834021
·
FEI: 3002808039
·
Expires 2026
Products
9
Proprietary Names
19
Establishment Types
1
Classifications
9
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Registration Details
- Registration Name
- RSR LTD.
- Registration Number
- 3003834021
- FEI Number
- 3002808039
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Parc Ty Glas, Llanishen
- City
- CARDIFF
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K070183
Owner / Operator
- Firm Name
- RSR Limited
- Operator Number
- 10023525
- Address
- Parc Ty Glas, Llanishen
- City
- Cardiff
- State
- GB-CRF
- Postal Code
- CF14 5DU
- Country
- GB
- Correspondent
- Jill Clark
US Agent
- Business Name
- FDAbasics
- Contact Name
- Emily Matorin
- Address
- 1 Prospect Park West Ste 4D
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insulin Autoantibody Kit | OCN | Class 2 | Immunology | No | 2007-11-29 |
| Autoantibodies, Glutamic Acid Decarboxylase (Gad) | NWG | Class 2 | Immunology | No | 2007-11-29 |
| Zinc Transporter 8 Auto-Antibody | PHF | Class 2 | Immunology | No | 2014-11-19 |
| Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking | NST | Class 2 | Immunology | No | 2007-11-29 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2007-11-29 |
| Tyrosine Phosphatase (Ia-2) Autoantibody Assay | OIF | Class 2 | Immunology | No | 2023-11-16 |
| 21-Hydroxylase Antibody (21-Ohab) | PCG | Class 2 | Immunology | No | 2019-11-07 |
| Voltage Gated Calcium Channel (Vgcc) Antibody Assay | PAF | Class 2 | Immunology | No | 2012-06-28 |
| Aquaporin-4 Autoantibody | PNI | Class 2 | Immunology | No | 2016-11-08 |
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
KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
KRONUS STEROID 21-HYDOXYLASE ANTIBODY (21-OHAB) RIA KIT
MODIFIED KRONUS TEST KIT FOR AUTOANTIBODIES TO TPO
Establishment Types
Manufacture Medical Device