No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B085K931M40 | K931M-4 | Audit MicroControls Cal Ver FLQ Drugs of Abuse for Roche Systems | |||||
2 | B085K947M50 | K947M-5 | Audit MicroControls Linearity FLQ Fertility for Abbott Systems | |||||
3 | B085K905M50 | K905M-5 | Audit MicroControls Linearity DROP LQ TIBC for Ortho Vitros | |||||
4 | B085K902M50 | K902M-5 | Audit MicroControls Linearity FD General Chemistry Panel 3 for Ortho Vitros | |||||
5 | B085K895M50 | K895M-5 | Audit MicroControls Control LQ Galectin-3 | |||||
6 | B085K891M50 | K891M-5 | Audit MicroControls Linearity FD Cardiac Siemens Stratus | |||||
7 | B085K805M50 | K805M-5 | Audit MicroControls Linearity FD Tumor Markers Siemens Atellica/Centaur | |||||
8 | B085K738M50 | K738M-5 | Audit MicroControls Linearity FD HE4, HER2 Tumor Markers | |||||
9 | B085K735M50 | K735M-5 | Audit MicroControls Linearity LQ Cystatin C | |||||
10 | B085K712M50 | K712M-5 | Audit MicroControls Linearity LQ Ammonia/Ethanol | |||||
11 | B085K081M60 | K081M-6 | Audit MicroControls Control LQ Galectin-3 | |||||
12 | B085K063M60 | K063M-6 | Audit MicroControls Control FD Immunoassay | |||||
13 | B085K941M50 | K941M-5 | Audit MicroControls Linearity FD General Chemistry Panel 2 for Abbott Systems | |||||
14 | B085K932M50 | K932M-5 | Audit MicroControls Linearity FLQ Troponin T for Roche Systems | |||||
15 | B085K921M50 | K921M-5 | Audit MicroControls Linearity LQ Anti-SARS-CoV-2 S for Roche Systems | |||||
16 | B085K906M50 | K906M-5 | Audit MicroControls Linearity FD Cardiac Markers for Ortho Vitros | |||||
17 | B085K904M50 | K904M-5 | Audit MicroControls Linearity FD iPTH for Ortho Vitros | |||||
18 | B085K887M50 | K887M-5 | Audit MicroControls Linearity FD Cardiac RAMP | |||||
19 | B085K883M50 | K883M-5 | Audit MicroControls Linearity FD D-Dimer PATHFAST Immunoanalyzer | |||||
20 | B085K809M50 | K809M-5 | Audit MicroControls Linearity FD Anemia Siemens Atellica/Centaur | |||||
21 | B085K804M50 | K804M-5 | Audit MicroControls Linearity FD Cardiac Markers Siemens Atellica/Centaur | |||||
22 | B085K803M50 | K803M-5 | Audit MicroControls Linearity FD BNP Siemens Atellica/Centaur | |||||
23 | B085K737M50 | K737M-5 | Audit MicroControls Linearity FD BNP (Extended) | |||||
24 | B085K736M50 | K736M-5 | Audit MicroControls Linearity DROP LQ Blood Glucose | |||||
25 | B085K729M50 | K729M-5 | Audit MicroControls Linearity LQ Vitamin D | |||||
26 | B085K720M50 | K720M-5 | Audit MicroControls Linearity LQ RF/CRP | |||||
27 | B085K717M50 | K717M-5 | Audit MicroControls Linearity FD D-Dimer | |||||
28 | B085K713M50 | K713M-5 | Audit MicroControls Linearity FD BNP (High) | |||||
29 | B085K079M60 | K079M-6 | Audit MicroControls Control FD HE4, HER2 Tumor Markers | |||||
30 | B085K078M80 | K078M-8 | Audit MicroControls Control DROP LQ Blood Glucose | |||||
31 | B085K0662100 | K0662-10 | Audit MicroControls Control FD Urine Chemistry | |||||
32 | B085K066110 | K0661-10 | Audit MicroControls Control FD Urine Chemistry | |||||
33 | B085K934M50 | K934M-5 | Audit MicroControls Linearity FD iPTH for Roche Systems | |||||
34 | B085K709M50 | K709M-5 | Audit MicroControls Linearity FD Lipids | |||||
35 | B085K982M50 | K982M-5 | Audit MicroControls Linearity FD Cardiac Markers for PATHFAST Immunoanalyzer | |||||
36 | B085K882M50 | K882M-5 | Audit MicroControls Linearity FD Lipids for Roche Systems | |||||
37 | B085K845M50 | K845M-5 | Audit MicroControls Linearity FD D-Dimer bioMerieux VIDAS and miniVIDAS | |||||
38 | B085K832M50 | K832M-5 | Audit MicroControls Linearity FD Thyroid for Abbott Systems | |||||
39 | B085K808M50 | K808M-5 | Audit MicroControls Linearity FD Fertility Siemens Centaur | |||||
40 | B085K719M50 | K719M-5 | Audit MicroControls Linearity FD Tumor Markers | |||||
41 | B085K701M50 | K701M-5 | Audit MicroControls Linearity FD General Chemistry | |||||
42 | B085K088M60 | K088M-6 | Audit MicroControls Control FD G6PD for Baebies FINDER | |||||
43 | B085K080M60 | K080M-6 | Audit MicroControls Control LQ Vitamin D for Roche Systems | |||||
44 | B085K074M60 | K074M-6 | Audit MicroControls Control LQ Serum Protein | |||||
45 | B085K071M60 | K071M-6 | Audit MicroControls Control FD Procalcitonin | |||||
46 | B085K070M60 | K070M-6 | Audit MicroControls Control FD Tumor Markers | |||||
47 | B085K068M60 | K068M-6 | Audit MicroControls Control FD TDM | |||||
48 | B085K065M40 | K065M-4 | Audit MicroControls Control DROPLQ Urine Dipstick | |||||
49 | B085K064M100 | K064M-10 | Audit MicroControls Control DROPLQ Urine Dipstick | |||||
50 | B085K935M50 | K935M-5 | Audit MicroControls Linearity FD Cardiac Markers for Roche Systems |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00886338000055 | S5800397 | S5800397 | Level 1 | UASure II Uric Acid Control Solution L1 | APEX BIOTECHNOLOGY CORP. |
2 | 00885502016038 | IGM-0008 | IGMHI | EasyGluco™ High Control Solution | U.S. DIAGNOSTICS INC. | |
3 | 00885502016007 | IGM-0024 | INFINITY™ High Control Solution | U.S. DIAGNOSTICS INC. | ||
4 | 00885502015031 | IGM-0008 | IGMLOW | EasyGluco™ Low Control Solution | U.S. DIAGNOSTICS INC. | |
5 | 00885502015000 | IGM-0024 | INFINITY™ Low Control Solution | U.S. DIAGNOSTICS INC. | ||
6 | 00885502004035 | IGM-0008 | IGMNORM | EasyGluco™ Normal Control Solution | U.S. DIAGNOSTICS INC. | |
7 | 00885502004004 | IGM-0024 | INFINITY™ Normal Control Solution | U.S. DIAGNOSTICS INC. | ||
8 | 00885502001034 | IGM-0008 | IGM-G2-103 | EasyGluco™G2 Meter Kit | U.S. DIAGNOSTICS INC. | |
9 | 00885502000037 | IGM-0008 | IGM-G2-101 | EasyGluco™G2 Starter Kit | U.S. DIAGNOSTICS INC. | |
10 | 00884883011533 | 0212 | DRI THC 125 ng/mL Urine Control | MICROGENICS CORPORATION | ||
11 | 00884883011496 | 0168 | DRI THC 60 ng/mL Urine Control | MICROGENICS CORPORATION | ||
12 | 00884883011441 | 0170 | DRI THC 40 ng/mL Urine Control | MICROGENICS CORPORATION | ||
13 | 00884883007772 | 10028306 | MAS SARS-CoV-2 Negative Control | MICROGENICS CORPORATION | ||
14 | 00884883007765 | 10028305 | MAS SARS-CoV-2 IgG Positive Control | MICROGENICS CORPORATION | ||
15 | 00884883006959 | 969035 | Acrometrix Syphilis | MICROGENICS CORPORATION | ||
16 | 00884883006942 | 960855 | Acrometrix AntiHBs | MICROGENICS CORPORATION | ||
17 | 00884883006928 | 960038 | Acrometrix HIV p24 | MICROGENICS CORPORATION | ||
18 | 00884883006553 | 965003 | Acrometrix HBV High Control | MICROGENICS CORPORATION | ||
19 | 00884883006546 | 964003 | Acrometrix HIV-1 High Control | MICROGENICS CORPORATION | ||
20 | 00884883006539 | 963003 | Acrometrix HCV High Control | MICROGENICS CORPORATION | ||
21 | 00884883006522 | 960501 | Acrometrix EV Low Control | MICROGENICS CORPORATION | ||
22 | 00884883006515 | 960499 | Acrometrix EV Negative Control | MICROGENICS CORPORATION | ||
23 | 00884883006508 | 965002 | Acrometrix HBV Mid Control | MICROGENICS CORPORATION | ||
24 | 00884883006492 | 965001 | Acrometrix HBV Low Control | MICROGENICS CORPORATION | ||
25 | 00884883006485 | 964002 | Acrometrix HIV-1 Mid Control | MICROGENICS CORPORATION | ||
26 | 00884883006478 | 964001 | Acrometrix HIV-1 Low Control | MICROGENICS CORPORATION | ||
27 | 00884883006461 | 963002 | Acrometrix HCV Mid Control | MICROGENICS CORPORATION | ||
28 | 00884883006454 | 963001 | Acrometrix HCV Low Control | MICROGENICS CORPORATION | ||
29 | 00884883006447 | 962000A | Acrometrix Negative Control | MICROGENICS CORPORATION | ||
30 | 00884883006430 | 961231 | Acrometrix EBV High Plasma Control | MICROGENICS CORPORATION | ||
31 | 00884883006423 | 961230 | Acrometrix EBV Low Plasma Control | MICROGENICS CORPORATION | ||
32 | 00884883006416 | 960091 | Acrometrix MRSA Positive Control | MICROGENICS CORPORATION | ||
33 | 00884883006409 | 960051 | Acrometrix BKV High Control | MICROGENICS CORPORATION | ||
34 | 00884883006393 | 960050 | Acrometrix BKV Low Control | MICROGENICS CORPORATION | ||
35 | 00884883006386 | 960041 | Acrometrix GBS Positive Control | MICROGENICS CORPORATION | ||
36 | 00884883006379 | 960025 | Acrometrix MSSA Positive Control | MICROGENICS CORPORATION | ||
37 | 00884883006027 | 963603 | Acrometrix BB NAT HBV Positive Control | MICROGENICS CORPORATION | ||
38 | 00884883005020 | 1404 | DRI THC 125 ng/mL Urine Control | MICROGENICS CORPORATION | ||
39 | 00884883005013 | 0214 | DRI THC 75 ng/mL Urine Control | MICROGENICS CORPORATION | ||
40 | 00884883005006 | 1402 | DRI THC 60 ng/mL Urine Control | MICROGENICS CORPORATION | ||
41 | 00884883004993 | 1401 | DRI THC 40 ng/mL Urine Control | MICROGENICS CORPORATION | ||
42 | 00884883004634 | 10014432 | MAS Bilirubin Liquid Assayed Bilirubin Control | MICROGENICS CORPORATION | ||
43 | 00884883004627 | 10014431 | MAS Bilirubin Liquid Assayed Bilirubin Control | MICROGENICS CORPORATION | ||
44 | 00884883004610 | 10014430 | MAS Bilirubin Liquid Assayed Bilirubin Control | MICROGENICS CORPORATION | ||
45 | 00884883004429 | DBCL-V | MAS Diabetes Liquid Assayed Diabetes Control | MICROGENICS CORPORATION | ||
46 | 00884883004078 | PTH-MP | MAS PTH Control Liquid Assayed PTH Control | MICROGENICS CORPORATION | ||
47 | 00884883003866 | BC-S1 | MAS Bilirubin Liquid Assayed Bilirubin Control | MICROGENICS CORPORATION | ||
48 | 00884883003859 | BC103 | MAS Bilirubin Liquid Assayed Bilirubin Control | MICROGENICS CORPORATION | ||
49 | 00884883003842 | BC102 | MAS Bilirubin Liquid Assayed Bilirubin Control | MICROGENICS CORPORATION | ||
50 | 00884883003835 | BC101 | MAS® Bilirubin Liquid Assayed Bilirubin Control | MICROGENICS CORPORATION |