FDA Registration
Active
🇬🇧 United Kingdom
Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)
Reg #: 3014607865
·
FEI: 3014607865
·
Expires 2025
Products
1
Proprietary Names
60
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- RANDOX LABORATORIES LIMITED
- Registration Number
- 3014607865
- FEI Number
- 3014607865
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 30 RANDALSTOWN ROAD
- City
- ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey
- Country
- GB
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 |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2018-06-18 |
Proprietary Names
Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)
LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)
Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)
LIQUID CARDIAC CONTROL 1
LIQUID IMMUNOASSAY CONTROL - LEVEL 1 (IA CONTROL 1)
APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1)
COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)
COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM LEVEL 2 (LIQ CHEM ASY PREMIUM 2)
LIQUID FROZEN LIPID CONTROL - LEVEL 1 (LIQ LPD CONTROL 1)
ASSAYED BOVINE MULTI SERA - LEVEL 2 (BOV ASY CONTROL 2)
CHEMISTRY PREMIUM - LEVEL 3 (CHEM PREMIUM 3)
CHEMISTRY PREMIUM - LEVEL 2 (CHEM PREMIUM 2)
APOLIPOPROTEIN CONTROL - LEVEL 2 (APO CONTROL 2)
BILIRUBIN ELEVATED SERUM (BIL CONTROL H)
LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1)
LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2)
APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R)
RANDOX SERUM DILUENT (DIL SM)
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM LEVEL 3 (LIQ CHEM ASY PREMIUM 3)
ASSAYED BOVINE MULTI SERA - LEVEL 1 (BOV ASY CONTROL 1)
SPECIFIC PROTEIN CONTROL - LEVEL 1 (SP CONTROL 1)
ESOTERIC LINEARITY VERIFIERS (For Roche Systems) (ESOTERIC LIN VER ROCHE)
LIQUID CSF CONTROL - LEVEL 1 (CSF CONTROL 1)
SPECIFIC PROTEIN CONTROL - LEVEL 2 (SP CONTROL 2)
LIQUID FROZEN LIPID CONTROL - LEVEL 3 (LIQ LPD CONTROL 3)
LIQUID CSF CONTROL - LEVEL 2 (CSF CONTROL 2)
CLINICAL CHEMISTRY LINEARITY VERIFIERS (For Roche Systems) (LIQ CLIN CHEM LIN VER)
ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
SPECIFIC PROTEIN CONTROL - LEVEL 3 (SP CONTROL 3)
APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3)
COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)
LIQUID BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2)
BILIRUBIN LINEARITY VERIFIER (For Roche Systems) (BILIRUBIN LIN VER ROCHE)
CO2/ELECTROLYTE LINEARITY VERIFIERS (For Roche Systems) (CO2 LIN VER)
LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC)
ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)
LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R)
APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Apo LinVer - BC)
LIAISON Endocrinology Calibration Verifiers
CYTOKINE CONTROL
CARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3)
CYTOKINE HIGH SENSITIVITY CONTROLS (CTK HS CONTROL)
CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1)
Liquid Frozen Bilirubin Control - Level 1
Liquid Frozen Bilirubin Control - Level 2
CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2)
ABAXIS CHEMISTRY CONTROL LEVEL 1
ABAXIS CHEMISTRY CONTROL LEVEL 2
SERUM INDICES (SERUM INDICES)
LIQUID CARDIAC CONTROL 2
LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)
PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3)
LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1)
LIQUID CARDIAC CONTROL 3
PRE-ECLAMPSIA CONTROL LEVEL 2 (Pre-eclampsia CONTROL 2)
LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)
LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)
PRE-ECLAMPSIA CONTROL LEVEL 1 (Pre-eclampsia CONTROL 1)
Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)