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
Phone
304 7282890

Products

Device Name Product Code
Multi-Analyte Controls, All Kinds (Assayed) JJY

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)