FDA Registration
Active
🇬🇧 United Kingdom
Atellica CH Uric Acid (UA)
Reg #: 3004493545
·
FEI: 3004493545
·
Expires 2025
Products
17
Proprietary Names
7
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- RANDOX LABORATORIES LIMITED
- Registration Number
- 3004493545
- FEI Number
- 3004493545
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 36 / 44 LARGY ROAD
- City
- CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K991576
Owner / Operator
- Firm Name
- RANDOX LABORATORIES, LTD.
- Operator Number
- 8020890
- Address
- 55 DIAMOND RD., --
- City
- CRUMLIN, CO.ANTRIM
- State
- GB-NOTA
- Postal Code
- BT29 4QY
- Country
- GB
- Correspondent
- Karena - Shaw
US Agent
- Business Name
- RANDOX LABORATORIES-US, LTD
- Contact Name
- Sammy Alnajm
- Address
- 515 Industrial Boulevard
- City
- Kearneysville
- State
- WV
- ZIP
- 25430
- Country
- US
- [email protected]
- Phone
- 304 7282890
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2006-09-08 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Nephelometric, Amylase | KHM | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes | CJK | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2006-09-08 |
| Titrimetric, Magnesium | CFO | Class 1 | Clinical Chemistry | No | 2006-09-08 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2006-09-08 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Cresolphthalein Complexone, Calcium | CIC | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2006-09-08 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2006-09-08 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2006-09-08 |
Proprietary Names
Atellica CH Uric Acid (UA)
Atellica CH Urea Nitrogen (UN_c)
Atellica CH Aspartate Aminotransferase (AST)
Atellica CH Inorganic Phosphorus (IP)
Atellica CH Albumin (Alb)
Atellica CH Calcium (Ca)
Atellica CH Iron_2 (Iron_2)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)