No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00856626006151 | 997-43801 | 997-43801 | In-Vitro Diagnostic Use | DAE | Complement C9, Antigen, Antiserum, Control | 2 | CH50 Calibrator |
2 | 14987481164595 | 993-72691 | 993-72691 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | 1 | L-Type HDL-C Reagent 2 |
3 | 14987481164427 | 993-61601 | 993-61601 | The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30. | NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma R Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | 2 | uTASWako Chip Cassette |
4 | 10856626006097 | 993-72691 | 993-72691 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | L-Type HDL-C Reagent 2 | |
5 | 10856626006080 | 993-61601 | 993-61601 | The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30. | NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma R Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | uTASWako Chip Cassette | |
6 | 04987481164673 | 991-06201 | 991-06201 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Autokit Micro Albumin Control Set |
7 | 04987481164512 | 997-43801 | 997-43801 | In-Vitro Diagnostic Use | DAE | Complement C9, Antigen, Antiserum, Control | 2 | CH50 Calibrator |
8 | 00856626006106 | 995-06101 | 995-06101 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Autokit Micro Albumin Calibrator Set |
9 | 14987481164588 | 997-72591 | 997-72591 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | 1 | L-Type HDL-C Reagent 1 |
10 | 14987481164564 | 991-00101 | 991-00101 | In-Vitro Diagnostic Use | JIS | Calibrator, Primary | 2 | L-Type HDL-C Reagent 1 |
11 | 14987481164540 | 999-00504 | 999-00504 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | 1 | L-Type LDL-C Reagent 2 |
12 | 10856626006196 | 997-72591 | 997-72591 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | L-Type HDL-C Reagent 1 | |
13 | 04987481164529 | 995-06101 | 995-06101 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Autokit Micro Albumin Calibrator Set |
14 | 14987481164502 | 991-60801 | 991-60801 | In-Vitro Diagnostic Use | NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma R Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | 2 | uTASWako Wash Solution |
15 | 10856626006059 | 991-60801 | 991-60801 | In-Vitro Diagnostic Use | NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma R Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | uTASWako Wash Solution | |
16 | 10856626006042 | 991-00101 | 991-00101 | The L-Type HDL-C is an in vitro assay for the quantitative determination of high The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in serum. (4 each 600 mL) | JIS | Calibrator, Primary | L-Type HDL-C (Reagent 1) | |
17 | 04987481164666 | 999-06001 | 999-06001 | In-Vitro Diagnostic Use | JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | Autokit Micro Albumin |
18 | 00856626006168 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | JIT | Calibrator, Secondary | 2 | uTASWako AFP-L3 Calibrator Set |
19 | 00856626006120 | 995-60701 | 995-60701 | In-Vitro Diagnostic Use | OAU | Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma | 2 | uTASWako DCP |
20 | 14987481164618 | 995-34791 | 995-34791 | In-Vitro Diagnostic Use | JLH | Titrimetric, Fatty Acids | 1 | HR Series NEFA-HR(2) Solvent A |
21 | 14987481164496 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | uTASWako DCP Control H |
22 | 10856626006066 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | uTASWako DCP Control H | |
23 | 04987481164437 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | JIT | Calibrator, Secondary | 2 | uTASWako AFP-L3 Calibrator Set |
24 | 04987481164413 | 995-60701 | 995-60701 | In-Vitro Diagnostic Use | OAU | Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma | 2 | uTASWako DCP |
25 | 14987481164632 | 993-35191 | 993-35191 | In-Vitro Diagnostic Use | JLH | Titrimetric, Fatty Acids | 1 | HR Series NEFA-HR(2) Solvent B |
26 | 14987481164489 | 995-61301 | 995-61301 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | uTASWako DCP Control L |
27 | 14987481164458 | 993-61101 | 993-61101 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | uTASWako AFP-L3 Control H |
28 | 10856626006134 | 995-61301 | 995-61301 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | uTASWako DCP Control L | |
29 | 10856626006073 | 993-61101 | 993-61101 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | uTASWako AFP-L3 Control H | |
30 | 00856626006205 | 999-60601 | 999-60601 | In-Vitro Diagnostic Use | NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma R Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | 2 | uTASWako AFP-L3 |
31 | 14987481164601 | 999-34691 | 999-34691 | In-Vitro Diagnostic Use | JLH | Titrimetric, Fatty Acids | 1 | HR Series NEFA-HR(2) Color Reagent A |
32 | 14987481164557 | 990-28011 | 990-28011 | In-Vitro Diagnostic Use | JIS | Calibrator, Primary | 2 | HDL-C/LDL-C Calibrator |
33 | 14987481164441 | 997-61001 | 997-61001 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | uTASWako AFP-L3 Control L |
34 | 14987481102924 | 464-01601 | 464-01601 | In-Vitro Diagnostic Use | JIX | Calibrator, Multi-Analyte Mixture | 2 | Multi Calibrator Lipids |
35 | 10856626006172 | 997-61001 | 997-61001 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | uTASWako AFP-L3 Control L | |
36 | 10856626006141 | 997-00201 | 997-00201 | The L-Type HDL-C is an in vitro assay for the quantitative determination of high The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in serum. (4 each 600 mL) | JIS | Calibrator, Primary | L-Type HDL-C (Reagent 2) | |
37 | 10856626006035 | 990-28011 | 990-28011 | In-Vitro Diagnostic Use | JIS | Calibrator, Primary | HDL-C/LDL-C Calibrator | |
38 | 10856626006028 | 464-01601 | 464-01601 | In-Vitro Diagnostic Use | JIX | Calibrator, Multi-Analyte Mixture | Multi Calibrator Lipids | |
39 | 04987481164642 | 997-76491 | 997-76491 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | NEFA Linearity Material |
40 | 04987481164390 | 999-60601 | 999-60601 | In-Vitro Diagnostic Use | NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma R Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | 2 | uTASWako AFP-L3 |
41 | 14987481164465 | 997-61501 | 997-61501 | In-Vitro Diagnostic Use | NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma R Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | 2 | uTASWako AFP-L3 Sample Dilution Buffer |
42 | 10856626006189 | 997-61501 | 997-61501 | In-Vitro Diagnostic Use | NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma R Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | uTASWako AFP-L3 Sample Dilution Buffer | |
43 | 00856626006229 | 991-60301 | 991-60301 | In-Vitro Diagnostic Use | OUE | Micro Total Analysis Instrument System | 2 | uTASWako i30 |
44 | 00856626006212 | 999-61201 | 999-61201 | In-Vitro Diagnostic Use | JIT | Calibrator, Secondary | 2 | uTASWako DCP Calibrator Set |
45 | 00856626006113 | 995-40801 | 995-40801 | In-Vitro Diagnostic Use | DAE | Complement C9, Antigen, Antiserum, Control | 2 | Autokit CH50 |
46 | 14987481164625 | 991-34891 | 991-34891 | In-Vitro Diagnostic Use | JLH | Titrimetric, Fatty Acids | 1 | HR Series NEFA-HR(2) Color Reagent B |
47 | 14987481164533 | 999-00404 | 999-00404 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | 1 | L-Type LDL-C Reagent 1 |
48 | 14987481100999 | 276-76491 | 276-76491 | In-Vitro Diagnostic Use | JIT | Calibrator, Secondary | 2 | NEFA Standard Solution |
49 | 10856626006011 | 276-76491 | 276-76491 | In-Vitro Diagnostic Use | JIT | Calibrator, Secondary | NEFA Standard Solution | |
50 | 04987481164680 | 991-60301 | 991-60301 | In-Vitro Diagnostic Use | OUE | Micro Total Analysis Instrument System | 2 | uTASWako i30 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10758750034895 | 6177750 | 6177750 | VITROS Immunodiagnostic ProductsAFP Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
2 | 10758750034659 | 6199330 | 6199330 | VITROS Immunodiagnostic ProductsProlactin Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
3 | 10758750009541 | 1681543 | 1681543 | VITROS Immunodiagnostic Products Cortisol Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
4 | 10758750009404 | 1614965 | 1614965 | VITROS Immunodiagnostic Products Total T3 Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
5 | 10758750008995 | 1393396 | 1393396 | VITROS Immunodiagnostic Products Total T4 Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
6 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
7 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
8 | 10758750008728 | 1286293 | 1286293 | VITROS Immunodiagnostic Products CK-MB Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
9 | 10758750008551 | 1209733 | 1209733 | VITROS Immunodiagnostic Products T3 Uptake Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
10 | 10758750008438 | 1112820 | 1112820 | VITROS Immunodiagnostic Products Free T3 Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
11 | 10758750004614 | 8254898 | 8254898 | VITROS Immunodiagnostic Products Progesterone Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
12 | 10758750002672 | 6802344 | 6802344 | VITROS Chemistry Products Calibrator Kit 29 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
13 | 10758750001675 | 6801896 | 6801896 | VITROS Chemistry Products Calibrator Kit 25 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
14 | 10758750001026 | 6801043 | 6801043 | VITROS Immunodiagnostic Products Myoglobin Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
15 | 10758750000210 | 1901263 | 1901263 | VITROS Immunodiagnostic ProductsFSH Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
16 | 08426950485612 | 00020010600 | 00020010600 | HemosIL ISI Calibrate | HemosIL ISI Calibrate | INSTRUMENTATION LABORATORY COMPANY |
17 | 08426950472483 | 00020300600 | 00020300600 | HemosIL Heparin Calibrators | HemosIL Heparin Calibrators | INSTRUMENTATION LABORATORY COMPANY |
18 | 08426950088974 | 82 3500 63 | 82 3500 63 | Calibration Plasma LMW Heparin | Calibration Plasma LMW Heparin | INSTRUMENTATION LABORATORY COMPANY |
19 | 08426950046677 | 00009832550 | 00009832550 | HCT CALIBRATOR 14 1600 SYNTH 50X2ML | Hct Calibrator | INSTRUMENTATION LABORATORY COMPANY |
20 | 07613336198261 | 09077871190 | 09077871190 | Elecsys FT3 III CalSet | ROCHE DIAGNOSTICS GMBH | |
21 | 07613336171769 | 09013296190 | 09013296190 | Elecsys HCG STAT CalSet II | ROCHE DIAGNOSTICS GMBH | |
22 | 07613336120392 | 08047545190 | 08047545190 | Calibrator ß2Microglobulin | ROCHE DIAGNOSTICS GMBH | |
23 | 07332699000461 | Calibrator | P000057 | Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Glucose, Lactate, Pyruvate, Glycerol and Glutamate. | Calibrator A | M DIALYSIS INC. |
24 | 05415168004770 | 08240400190 | 08240400190 | Calibration of Alpha2-Macroglobulin assay on cobas c501/502 systems. | Alpha2-Macroglobulin CAL KIT | DIAGAM |
25 | 05391516741545 | 30550 | 30550 | ACE Calibrator | Trinity Biotech | CLARK LABORATORIES, INC. |
26 | 05055273204445 | LP3406 | Randox Lipoprotein(a) level 3 control is based on lyophilised human serum contai Randox Lipoprotein(a) level 3 control is based on lyophilised human serum containing Lipoprotein(a). | LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) | RANDOX LABORATORIES LIMITED | |
27 | 05055273204438 | LP3404 | LP3404 | This product is intended for use in the calibration of Lipoprotein(a) assays. | Lp(a) CAL SET | RANDOX LABORATORIES LIMITED |
28 | 05055273201727 | CP2499 | CP2499 | The device is intended for in vitro diagnostic use in the calibration of CRP ass The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems. | CRP CAL | RANDOX LABORATORIES LIMITED |
29 | 05055273201697 | CP2479 | CP2479 | The device is intended for in vitro diagnostic use in the calibration of CRP ass The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems. | CRP CAL | RANDOX LABORATORIES LIMITED |
30 | 05055273201680 | CP2478 | CP2478 | The device is intended for in vitro diagnostic use in the calibration of CRP ass The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems. | hsCRP CAL | RANDOX LABORATORIES LIMITED |
31 | 05055273201659 | CP2179 | CP2179 | The device is intended for in vitro diagnostic use in the calibration of CRP ass The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems. | CRP CAL | RANDOX LABORATORIES LIMITED |
32 | 05055273201239 | CH2673 | CH2673 | The device is intended for in vitro diagnostic use in the calibration of Randox The device is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL cholesterol clearance methods | D LDL/HDL CAL | RANDOX LABORATORIES LIMITED |
33 | 05051700020381 | NC022.A | Complement C2 Calibrator Set | THE BINDING SITE GROUP LIMITED | ||
34 | 05051700016841 | LK098.S | Lipoprotein (a) Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
35 | 04987170775579 | NK-8320 | Calibration Standard1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glyc Calibration Standard1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control | GLYCOMARK | NIPPON KAYAKU CO., LTD. | |
36 | 04560189211773 | N/A | AIA-PACK CEA Calibration Set | TOSOH CORPORATION | ||
37 | 04560189211254 | N/A | AIA-PACK TSH 3rd-Gen CALIBRATOR SET | TOSOH CORPORATION | ||
38 | 04560189211155 | N/A | AIA-PACK AFP Calibrator Set | TOSOH CORPORATION | ||
39 | 04560189211117 | N/A | AIA-PACK CA 19-9 Calibrator Set | TOSOH CORPORATION | ||
40 | 04260341780603 | 30.9.0290 | 30.9.0290 | OSMOREF® Reference Solution is intended for use in evaluating the performance of OSMOREF® Reference Solution is intended for use in evaluating the performance of customer osmometers. It is an independent reference for checking the linearity of the instrument in the osmolality range of normal serum. | GONOTEC Reference Solution OSMOREF® 290 mOsmol/kg, 10x1ml | G O N O T E C GESELLSCHAFT FÜR MESS- UND REGELTECHNIK MBH. |
41 | 04260341780597 | 30.9.2000 | 30.9.2000 | Calibration standards are used to calibrate and/or check the performance of cust Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel. | GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O - 10 x 1mL | G O N O T E C GESELLSCHAFT FÜR MESS- UND REGELTECHNIK MBH. |
42 | 04260341780580 | 30.9.0850 | 30.9.0850 | Calibration standards are used to calibrate and/or check the performance of cust Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel. | GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O - 10 x 1mL | G O N O T E C GESELLSCHAFT FÜR MESS- UND REGELTECHNIK MBH. |
43 | 04260341780573 | 30.9.0500 | 30.9.0500 | Calibration standards are used to calibrate and/or check the performance of cust Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel. | GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O - 10 x 1mL | G O N O T E C GESELLSCHAFT FÜR MESS- UND REGELTECHNIK MBH. |
44 | 04260341780566 | 30.9.0100 | 30.9.0100 | Calibration standards are used to calibrate and/or check the performance of cust Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel. | GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O - 10 x 1mL | G O N O T E C GESELLSCHAFT FÜR MESS- UND REGELTECHNIK MBH. |
45 | 04260341780559 | 30.9.0020 | 30.9.0020 | Calibration standards are used to calibrate and/or check the performance of cust Calibration standards are used to calibrate and/or check the performance of customer osmometers by qualified personnel. | GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O - 10 x 1mL | G O N O T E C GESELLSCHAFT FÜR MESS- UND REGELTECHNIK MBH. |
46 | 04015630934850 | 7030207190 | 7030207190 | Elecsys CA 125 II CalSet II | ROCHE DIAGNOSTICS GMBH | |
47 | 04015630930913 | 6437222190 | 6437222190 | Elecsys FT3 III CalSet | ROCHE DIAGNOSTICS GMBH | |
48 | 04015630919628 | 3052028190 | 3052028190 | Elecsys SHBG CalSet | ROCHE DIAGNOSTICS GMBH | |
49 | 04015630919406 | 3302652190 | 3302652190 | Elecsys HCG CalSet | ROCHE DIAGNOSTICS GMBH | |
50 | 04015630919390 | 3303071190 | 3303071190 | Elecsys HCG STAT CalSet | ROCHE DIAGNOSTICS GMBH |