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 | 14987481164571 | 997-00201 | 997-00201 | In-Vitro Diagnostic Use | JIS | Calibrator, Primary | 2 | L-Type HDL-C Reagent 2 |
4 | 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 |
5 | 10856626006097 | 993-72691 | 993-72691 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | L-Type HDL-C Reagent 2 | |
6 | 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 | |
7 | 04987481164673 | 991-06201 | 991-06201 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Autokit Micro Albumin Control Set |
8 | 04987481164512 | 997-43801 | 997-43801 | In-Vitro Diagnostic Use | DAE | Complement C9, Antigen, Antiserum, Control | 2 | CH50 Calibrator |
9 | 00856626006106 | 995-06101 | 995-06101 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Autokit Micro Albumin Calibrator Set |
10 | 14987481164588 | 997-72591 | 997-72591 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | 1 | L-Type HDL-C Reagent 1 |
11 | 14987481164564 | 991-00101 | 991-00101 | In-Vitro Diagnostic Use | JIS | Calibrator, Primary | 2 | L-Type HDL-C Reagent 1 |
12 | 14987481164540 | 999-00504 | 999-00504 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | 1 | L-Type LDL-C Reagent 2 |
13 | 10856626006196 | 997-72591 | 997-72591 | In-Vitro Diagnostic Use | LBR | Ldl & Vldl Precipitation, Hdl | L-Type HDL-C Reagent 1 | |
14 | 04987481164529 | 995-06101 | 995-06101 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Autokit Micro Albumin Calibrator Set |
15 | 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 |
16 | 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 | |
17 | 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) | |
18 | 04987481164666 | 999-06001 | 999-06001 | In-Vitro Diagnostic Use | JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | Autokit Micro Albumin |
19 | 00856626006168 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | JIT | Calibrator, Secondary | 2 | uTASWako AFP-L3 Calibrator Set |
20 | 00856626006120 | 995-60701 | 995-60701 | In-Vitro Diagnostic Use | OAU | Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma | 2 | uTASWako DCP |
21 | 14987481164618 | 995-34791 | 995-34791 | In-Vitro Diagnostic Use | JLH | Titrimetric, Fatty Acids | 1 | HR Series NEFA-HR(2) Solvent A |
22 | 14987481164496 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | uTASWako DCP Control H |
23 | 10856626006066 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | uTASWako DCP Control H | |
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 | 00884883012592 | 10015573 | QMS Tacrolimus Immunoassay Calibrator Set | MICROGENICS CORPORATION | ||
2 | 00857969006006 | S2-76 | S2-76 | KIT, DIRECT TIBC CALIBRATOR | ACE | ALFA WASSERMANN, INC. |
3 | 00856626006212 | 999-61201 | 999-61201 | In-Vitro Diagnostic Use | uTASWako DCP Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
4 | 00856626006168 | 997-60901 | 997-60901 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
5 | 00853366007288 | 16-218 | 16-218 | K Calibrator for Roche / Hitachi Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
6 | 00852553007322 | 9575 | Calibrator / Calibration Verifier | Bilirubin Mid-Range Standard | VERICHEM LABORATORIES, INC. | |
7 | 00852553007308 | 9456 | Calibration Verifier | Tru-Zero Bilirubin Standard | VERICHEM LABORATORIES, INC. | |
8 | 00852553007117 | 9459 | Calibrator / Calibration Verifier | BR2 Bilirubin Calibrator | VERICHEM LABORATORIES, INC. | |
9 | 00852553007070 | 9436 | Calibrator / Calibration Verifier | Bilirubin Standard, Level F | VERICHEM LABORATORIES, INC. | |
10 | 00852553007063 | 9450 | Calibrator / Calibration Verifier | Bilirubin Standard Kit | VERICHEM LABORATORIES, INC. | |
11 | 00852169008270 | MAL1010 | MAL1010 | In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL | ClearChem Diagnostics Inc. MicroAlbumin | CLEARCHEM DIAGNOSTICS INC. |
12 | 00847865011624 | 6633720 | 6633720 | 25-OH Vitamin D Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
13 | 00847865011617 | 6633700 | 6633700 | 25-OH Vitamin D Calibrator Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
14 | 00847817020155 | 290-1006 | 2901006 | D-100 HbA1c Calibrator Pack | D-100 | BIO-RAD LABORATORIES, INC. |
15 | 00847817015953 | 290-1004 | 2901004 | D-100 HbA1c Analytical Cartridge/Calibrator Pack | D-100 | BIO-RAD LABORATORIES, INC. |
16 | 00847817003509 | 220-0218 | 2200218 | D-10 Dual Program HbA2/F/A1c Calibrator/Diluent Set | D-10 Dual | BIO-RAD LABORATORIES, INC. |
17 | 00847817003394 | 220-0128 | 2200128 | D-10 Dual Program HbA1c Calibrator/Diluent Set | D-10 Dual | BIO-RAD LABORATORIES, INC. |
18 | 00847817003363 | 220-0119 | 2200119 | Calibrator Diluent | Calibrator Diluent | BIO-RAD LABORATORIES, INC. |
19 | 00847817003356 | 220-0118 | 2200118 | D-10 Hemoglobin A1c Program Calibrator/Diluent Set | D-10 | BIO-RAD LABORATORIES, INC. |
20 | 00845275003772 | TS3000 | Thermo Scientific | FISHER DIAGNOSTICS | ||
21 | 00842768039041 | 10714029 | KC331 | Alkaline Phosphatase Calibrator, 3 x 1mL | Dimension Vista® ALPI CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
22 | 00842768039027 | 10714028 | DC150 | Alkaline Phosphatase calibrator, 3x2x1mL | Dimension® ALPI CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
23 | 00842768035432 | 10700796 | DC207 | Tacrolimus Calibrator, Levels 1-5, 2 bottles each | Dimension® TAC Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
24 | 00842768034329 | 10476170 | DC143 | Enzyme II Calibrator, 2x3x1.5mL | Dimension® ENZ II CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
25 | 00842768033322 | 10636333 | KC470 | DGTX Calibrator, 2x5x5.0mL | Dimension Vista® DGTX CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
26 | 00842768029974 | 10470481 | K3105A | HbA1c Kit containing Hemoglobin A1c Flex® reagent cartridge, 240 tests, and HbA1 HbA1c Kit containing Hemoglobin A1c Flex® reagent cartridge, 240 tests, and HbA1c Calibrator (5 levels) | Dimension Vista® Flex® reagent cartridge HbA1c KIT | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
27 | 00842768029325 | 10488444 | KC604 | LOCI 6 Calibrator, 2x5x2mL | Dimension Vista® LOCI 6 CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
28 | 00842768026911 | 10464346 | KC350 | Enzyme 5 Calibrator, 3x1.5mL | Dimension Vista® ENZ 5 CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
29 | 00842768026904 | 10735073 | DC56A | DM/VS Lipase Calibrator | Siemens | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
30 | 00842768026324 | 10464529 | RC623 | LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL | Dimension® NTP CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
31 | 00842768026218 | 10284680 | DC35 | Enzyme I Calibrator, 2x2x1.5mL | Dimension® ENZ 1 CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
32 | 00842768025419 | 10464578 | KC270 | Enzymatic Creatinine Calibrator, 3x2x2.5mL | Dimension Vista® ECREA CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
33 | 00842768025228 | 10460278 | DC56 | Lipase Calibrator, 2x3x1mL | Dimension® LIPL CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
34 | 00842768025129 | 10464322 | KC676A | N-terminal Pro-Brain Natriuretic Peptide Calibrator, 2x6x1mL | Dimension Vista® PNBP CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
35 | 00842768022074 | 10464336 | RC621 | LOCI Cardiac Troponin I Calibrator, 2x5x2mL | Dimension® TNI CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
36 | 00842768022012 | 10464328 | DC48B | AHDL Calibrator, 2x3x1mL | Dimension® AHDL CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
37 | 00842768019722 | 10445087 | CPBNPM-C | The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in vitro di The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ pBNP method. | Stratus® CS Acute Care™ pBNP CalPak | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
38 | 00842768017919 | 10445195 | KC672 | Mass Creatine Kinase MB Isoenzyme Calibrator, 2x4x1mL / 2x2x1.5mL | Dimension Vista® MMB CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
39 | 00842768016912 | 10445008 | RC423A | N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL | Dimension® PBNP Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
40 | 00842768016738 | 10445197 | KC678 | Cardiac Troponin I Calibrator, 2x6x1mL | Dimension Vista® CTNI CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
41 | 00842768016714 | 10445194 | KC660 | LOCI 1 Calibrator, 2x4x1.5mL / 2x2x2mL | Dimension Vista® LOCI 1 CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
42 | 00842768016516 | 10445192 | KC632 | Beta Human Chorionic Gonadotropin Calibrator, 2x4x1mL / 2x2mL / 2x1.5mL | Dimension Vista® BHCG CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00842768016509 | 10445191 | KC624 | Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL | Dimension Vista® MYO CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
44 | 00842768016431 | 10445178 | KC260 | Urinary/Cerebrospinal Fluid Protein Calibrator, 3x1.5mL | Dimension Vista® UCFP CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
45 | 00842768016257 | 10445203 | K840 | V-LYTE® Dilution Check, 6x2mL | Dimension Vista® V-LTYE® Dilution Check | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
46 | 00842768016240 | 10445202 | K835 | V-LYTE® Diluent, 2x1.5 L | Dimension Vista® V-LTYE® Diluent 3 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00842768016233 | 10445201 | K825 | V-LYTE Standard B/Salt Bridge, 2x125mL | Dimension Vista® V-LTYE® Standard B V-LYTE® Salt Bridge 1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00842768016226 | 10445200 | K820 | V-LYTE® Standard A, 2x1.5 L | Dimension Vista® V-LTYE® Standard A 2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00842768015854 | 10445176 | KC240 | Iron Calibrator, 3x1.2mL | Dimension Vista® IRON CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00842768015823 | 10460279 | KC210 | Bilirubin Calibrator, 3x2.5 mL | Dimension Vista® BILI CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |