No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05055273207071 | CPL4017 | DDB | Ceruloplasmin, Antigen, Antiserum, Control | 2 | CERULOPLASMIN (CPL) | ||
2 | 05055273203400 | GR2368 | KQF | Assay, Glutathione Reductase | 2 | GLUTATHIONE REDUCTASE (GLUT RED) | ||
3 | 05055273209587 | UP8113 | JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | TOTAL PROTEIN (UP) | ||
4 | 05055273207118 | LUN5048 | OHQ | Multi-Analyte Controls Unassayed | 1 | LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2) | ||
5 | 05055273207163 | LUL5093 | OHQ | Multi-Analyte Controls Unassayed | 1 | LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1) | ||
6 | 05055273204322 | LO3999 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
7 | 05055273203516 | GY1369 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GLYCEROL CONTROL (GLY CONTROL) | ||
8 | 05055273203066 | FA115 | JLG | Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids | 1 | Non-Esterified Fatty Acids (NEFA) | ||
9 | 05055273200164 | AL1205 | AL1205 | CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | ALANINE AMINOTRANSFERASE (ALT) | |
10 | 05055273217766 | AMH10516 | AMH10516 | The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 4 (AMH10516) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 4 (AMH10516) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AMH CONTROL LEVEL 4 (AMH CONTROL 4) |
11 | 05055273217667 | CQ10430 | CQ10430 | This product is intended for in vitro use, in the quality control of Cardiac Mar This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) |
12 | 05055273215205 | LE10175 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2) | ||
13 | 05055273215175 | BR10172 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) | ||
14 | 05055273214338 | RX4045 | RX4045 | This is required for measuring reference electrode potential of an ion selective This is required for measuring reference electrode potential of an ion selective electrode module. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | REF SOLN |
15 | 05055273214307 | RP8398 | RP8398 | The Reagent Precision Test is used on the RX series clinical chemistry systems f The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RABS |
16 | 05055273213966 | CH2656 | Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cholesterol in human serum and plasma. | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | |
17 | 05055273210378 | RX8106 | RX8106 | Antibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ANTI-BACTERIAL DETERGENT (Detergent) |
18 | 05055273209389 | SA8396 | SA8396 | This product should be used in conjunction with RX daytona plus reagents to dilu This product should be used in conjunction with RX daytona plus reagents to dilute samples prior to assay. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | NS |
19 | 05055273209211 | LP8007 | MSJ | Apolipoproteins | 1 | APOLIPOPROTEIN A-I (APO A-I) | ||
20 | 05055273209204 | LP5047 | JIT | Calibrator, Secondary | 2 | APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) | ||
21 | 05055273209181 | LO8305 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
22 | 05055273209174 | LO8015 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
23 | 05055273209143 | LM4005 | LM4005 | The product is intended for the quantitative in vitro determination of Lithium in serum. | NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 2 | Li 2 |
24 | 05055273209020 | LAN4216 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM – LEVEL 2 (LIQ CHEM ASY PREMIUM 2) | ||
25 | 05055273208634 | CR8316 | CR8316 | The is intended for the quantitative in vitro diagnostic determination of Creati The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine | CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | CREA |
26 | 05055273208498 | CH8312 | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | ||
27 | 05055273208481 | CH8311 | For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | |
28 | 05055273208467 | CH8033 | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | ||
29 | 05055273208450 | CH8032 | MRR | System, Test, Low Density, Lipoprotein | 1 | DIRECT LDL-CHOLESTEROL (LDL) | ||
30 | 05055273208412 | CH1383 | Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cho Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma. | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | DIRECT HDL-CHOLESTEROL (HDL) | |
31 | 05055273208047 | DA4011 | DA4011 | The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-qu The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) in human urine. | DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | BZG |
32 | 05055273207958 | DA3127 | DA3127 | The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Cont The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 1 contains the specific drug Cannabinoid. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | THC CONTROL 1 |
33 | 05055273207330 | IAS3118 | This product is intended for in vitro diagnostic use, in the quality control of This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. Thismaterial can be used to monitor the control of accuracy or the control of reproducibility of immunoassays. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | IMMUNOASSAY SPECIALITY II - LEVEL 2 (IA SPECIALITY II LEV 2) | |
34 | 05055273207880 | DA2704 | DA2704 | The Randox Multidrug Calibrator Set is intended for use in the calibration of Me The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays. | DKB,DLJ | Calibrators, Drug Mixture,Calibrators, Drug Specific | 2 | DOA CAL |
35 | 05055273207866 | DA2702 | DA2702 | The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-e The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. | DKB | Calibrators, Drug Mixture | 2 | EDDP CAL |
36 | 05055273207781 | RX4041 | RX4041 | The Randox RX daytona plus without ISE is a fully automated, random access, clin The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RX daytona plus |
37 | 05055273207774 | RX4040 | RX4040 | The Randox RX daytona plus with ISE is a fully automated, random access, clinica The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser completewith dedicated analyser software. | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | RX daytona plus |
38 | 05055273207644 | CG5023 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) | ||
39 | 05055273207262 | IA3110 | This product is intended for in vitro diagnostic use, as assayed quality control This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | IMMUNOASSAY PREMIUM PLUS - LEVEL 2 (IA PREMIUM PLUS 2) | |
40 | 05055273207248 | LIA3108 | The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays statedin this package insert. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3) | |
41 | 05055273206456 | TD3414 | TD3414 | For the quantitative in vitro determination of Valproic Acid in human serum | LEG | Enzyme Immunoassay, Valproic Acid | 2 | VPA |
42 | 05055273206173 | SE1086 | OHQ | Multi-Analyte Controls Unassayed | 1 | BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3) | ||
43 | 05055273206111 | SA3854 | SA3854 | This product should be used in conjunction with RX series reagents to dilute sam This product should be used in conjunction with RX series reagents to dilute samples prior to assay | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | NS |
44 | 05055273205091 | RP3857 | RP3857 | The Reagent Precision Test is used on the RX series clinical chemistry systems f The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system. | JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | RABS |
45 | 05055273204315 | LO3998 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | ANTI-STREPTOLYSIN-O 2 (ASO 2) | ||
46 | 05055273204049 | IT2692 | IT2692 | Liquid Protein Calibrators are an in vitro diagnostic product used for the calib Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of Alpha-1-Antitrypsin, Alpha-1-Acid glycoprotein, IgA, IgG and IgM assays that require sample pre-dilution. | JIX | Calibrator, Multi-Analyte Mixture | 2 | SP CAL (LIQ) |
47 | 05055273204032 | IT2691 | IT2691 | Liquid Protein Calibrators are an in vitro diagnostic product used for the calib Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, RF and Transferrin assays. | JIX | Calibrator, Multi-Analyte Mixture | 2 | SP CAL (LIQ) |
48 | 05055273203783 | HN1530 | The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target valu The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 2 (HUM ASY CONTR | |
49 | 05055273202458 | EV3550 | EV3550 | Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser. | DKB | Calibrators, Drug Mixture | 2 | DOA CAL |
50 | 05055273202397 | EV3542 | EV3542 | The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays. | DIO,DJR,DKZ,DIS,JXM,LDJ,DJG,LCM | Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadon Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Benzodiazepine,Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Phencyclidine | 2 | DOA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00695684591007 | 59100 | Dipstick reagent strips for the qualitative detection of the following : Glucose Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, and Nitrite in Urine. | AIMSTRIP US-9 | GERMAINE LABORATORIES, INC | |
2 | 00695684551001 | 55100 | Dipstick reagent strips for the qualitative detection of the following : Blood, Dipstick reagent strips for the qualitative detection of the following : Blood, Glucose, Protein, Ketone and pH in Urine. | AIMSTRIP US-5 | GERMAINE LABORATORIES, INC | |
3 | 00695684511111 | 51111 | AIMSTRIP US-11 | GERMAINE LABORATORIES, INC | ||
4 | 00695684511005 | 51100 | Dipstick reagent strips for the qualitative detection of the following : Glucose Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine. | AIMSTRIP 10-SG | GERMAINE LABORATORIES, INC | |
5 | 00695684501211 | 50121 | Dipstick reagent strips for the qualitative detection of Ketone in Urine. | AIMSTRIP US-K | GERMAINE LABORATORIES, INC | |
6 | 00695684131005 | 13100 | Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC. | AIMTAB KETONE TABLETS | GERMAINE LABORATORIES, INC | |
7 | 00682607200412 | U031-111 | Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
8 | 00682607200405 | U031-101 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
9 | 00682607200399 | U031-091 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
10 | 00682607200382 | U031-081 | Mission Urinalysis Reagent Strips (PH/GLU/BIL/PRO/URO/NIT/LEU/KET) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
11 | 00682607200368 | U031-081 | Mission Urinalysis Reagent Strips (GLU/KET/SG/BLO/PH/PRO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
12 | 00682607200351 | U031-081 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
13 | 00682607200344 | U031-071 | Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
14 | 00682607200283 | U031-051 | Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH/BLO) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
15 | 00682607200252 | U031-041 | Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
16 | 00682607200207 | U031-031 | Mission Urinalysis Reagent Strips (GLU/KET/PH) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
17 | 00682607200191 | U031-031 | Mission Urinalysis Reagent Strips (GLU/KET/PRO) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
18 | 00682607200122 | U031-021 | Mission Urinalysis Reagent Strips (GLU/KET) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
19 | 00682607200092 | U031-011 | Mission Urinalysis Reagent Strips (KET) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
20 | 00682607000685 | U031-111 | Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
21 | 00682607000678 | U031-101 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
22 | 00682607000661 | U031-091 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
23 | 00682607000654 | U031-081 | Mission Urinalysis Reagent Strips (PH/GLU/BIL/PRO/URO/NIT/LEU/KET) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
24 | 00682607000630 | U031-081 | Mission Urinalysis Reagent Strips (GLU/KET/SG/BLO/PH/PRO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
25 | 00682607000623 | U031-081 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
26 | 00682607000616 | U031-071 | Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
27 | 00682607000555 | U031-051 | Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH/BLO) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
28 | 00682607000524 | U031-041 | Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
29 | 00682607000470 | U031-031 | Mission Urinalysis Reagent Strips (GLU/KET/PH) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
30 | 00682607000463 | U031-031 | Mission Urinalysis Reagent Strips (GLU/KET/PRO) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
31 | 00682607000395 | U031-021 | Mission Urinalysis Reagent Strips (GLU/KET) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
32 | 00682607000364 | U031-011 | Mission Urinalysis Reagent Strips (KET) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
33 | 00664816000045 | URS-05PR-7777 | Urine reagent strips; 5-parameter; 100 strips per vial | Urine Reagent Strips, 5-parameter | LW SCIENTIFIC, INC. | |
34 | 00664816000021 | URS-10PR-7777 | Urine reagent strips; 10-parameter; 100 strips per vial | Urine Reagent Strips, 10-parameter | LW SCIENTIFIC, INC. | |
35 | 00664816000014 | URS-01PR-KE77 | Urine reagent strips; 1-parameter; ketone; 100 strips per vial | Urine Reagent Strips, 1-parameter, ketone | LW SCIENTIFIC, INC. | |
36 | 00657498002254 | 7020-100 | 7020-100 | The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with th The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. | STAT-Site WB B-Ketone Test Strips | STANBIO LABORATORY, L.P. |
37 | 00657498002247 | 7020-050 | 7020-050 | The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with th The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. | STAT-Site WB B-Ketone Test Strips | STANBIO LABORATORY, L.P. |
38 | 00657498002230 | 7020-025 | 7020-025 | The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with th The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. | STAT-Site WB B-Ketone Test Strips | STANBIO LABORATORY, L.P. |
39 | 00657498002131 | 4000-100 | 4000-100 | Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. | Nitro-tab Ketone Tablets | STANBIO LABORATORY, L.P. |
40 | 00657498000731 | 401020 | 401020 | The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to acc The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma. | STAT-Site M B-HB Code Key | STANBIO LABORATORY, L.P. |
41 | 00657498000526 | B2440-180 | B2440-180 | For the Quantitative Determination of ß-Hydroxybutyrate in Serum or Plasma. | Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor® | STANBIO LABORATORY, L.P. |
42 | 00657498000519 | 2440-058 | 2440-058 | For the Quantitative Determination of ß-Hydroxybutyrate in Human Serum or Plasma. | B-Hydroxybutyrate LiquiColor® | STANBIO LABORATORY, L.P. |
43 | 00657498000120 | 202000 | 202000 | STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range of 0 – 2 mM. Additionally, the diluent helps to eliminate possible matrix effects caused by interfering substances such as acetoacetate. | STAT-Site Diluent | STANBIO LABORATORY, L.P. |
44 | 00657498000113 | 303500 | 303500 | The STAT-Site® Linearity Check is intended to be used to perform a linearity eva The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter. | STAT-Site Linearity Check | STANBIO LABORATORY, L.P. |
45 | 00657498000106 | 303000 | 303000 | STAT-Site® Controls are intended to be used to verify the procedural reliability STAT-Site® Controls are intended to be used to verify the procedural reliability of the assay for β-hydroxybutyrate using STAT-Site® Mβ-HB Meter and Test Strips. | STAT-Site B-HB Controls | STANBIO LABORATORY, L.P. |
46 | 00657498000090 | 401010 | 401010 | The STAT-Site® M β-HB Test is intended for the quantitative determination of th The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only. | STAT-Site M B-HB Strips | STANBIO LABORATORY, L.P. |
47 | 00657498000083 | 400400 | 400400 | The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to acc The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma. | STAT-Site M B-HB Analyzer Pack | STANBIO LABORATORY, L.P. |
48 | 00630414981147 | 10697937 | 10697937 | The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urin The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu | CLINITEK Novus® Automated Urine Chemistry Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00630414981130 | 10494134 | 10494134 | The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urin The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu | CLINITEK Novus® Automated Urine Chemistry Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00630414607962 | 11537761 | 11537761 | The CLINITEK Status Connector is intended for use with the CLINITEK Status+ anal The CLINITEK Status Connector is intended for use with the CLINITEK Status+ analyzer.The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect system. | Clinitek Status Connector | SIEMENS HEALTHCARE DIAGNOSTICS INC. |