No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00875197005936 | 07972466190 | 07972466190 | cobas Zika (480 tests) | ||||
2 | 00365702398108 | 5530199160 | 5530199160 | GJS | TEST, TIME, PROTHROMBIN | 2 | CoaguChek XS Pro Kit | |
3 | 00075537180075 | 11379194160 | 11379194160 | KHE | REAGENT, OCCULT BLOOD | 2 | Calibration Strip (Urisys 1100, cobas u 411) | |
4 | 00075537018934 | 11893467160 | 11893467160 | CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | 1 | Chemstrip 5 OB Test Strips | |
5 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | MZF | Test, HIV detection | 2 | Elecsys HIV Duo |
6 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
7 | 07613336179512 | 09205683001 | 09205683001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro transport line | |
8 | 07613336179499 | 09205632001 | 09205632001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro SSU | |
9 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
10 | 07613336171677 | 09007784190 | 09007784190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
11 | 07613336171660 | 09007741190 | 09007741190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
12 | 07613336170212 | 08924180160 | 08924180160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
13 | 07613336170182 | 08924163160 | 08924163160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
14 | 07613336166949 | 08836973190 | 08836973190 | MZF | Test, HIV detection | 2 | Elecsys HIV Duo | |
15 | 07613336164884 | 08764760190 | 08764760190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
16 | 07613336159804 | 04985354160 | 04985354160 | Anti-HBs CC 3 Elecsys | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | Anti-HBs CalCheck |
17 | 07613336158784 | 08463662001 | 08463662001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas c 503 analytical unit | |
18 | 07613336155332 | 08372284001 | 08372284001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
19 | 07613336155318 | 08376824190 | 08376824190 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
20 | 07613336154403 | 03500373190 | 03500373190 | MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Ca Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | free PSA CalCheck | |
21 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
22 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
23 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
24 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
25 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
26 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
27 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
28 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
29 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
30 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
31 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
32 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
33 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
34 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
35 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
36 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
37 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
38 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
39 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
40 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
41 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
42 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
43 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
44 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
45 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
46 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
47 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
48 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
49 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
50 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 15099590575281 | 442785 | 442785 | Uric Acid Reagent (URIC 2 x 300) | Synchron | BECKMAN COULTER, INC. |
2 | 15099590060152 | OSR6698 | Uric Acid | AU | BECKMAN COULTER, INC. | |
3 | 15099590020385 | OSR6298 | Uric Acid | AU | BECKMAN COULTER, INC. | |
4 | 15099590010942 | OSR6198 | Uric Acid | AU | BECKMAN COULTER, INC. | |
5 | 15099590000349 | OSR6098 | Uric Acid | AU | BECKMAN COULTER, INC. | |
6 | 10758750000340 | 1943927 | 1943927 | VITROS Chemistry Products URIC Slides | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
7 | 08806141303077 | 31H0P | One+Step Uric Acid | DFI CO.,LTD | ||
8 | 07613336121580 | 08058750190 | 08058750190 | Uric Acid ver.2 | ROCHE DIAGNOSTICS GMBH | |
9 | 05060500091972 | IR460-1200 | IR460-1200 | Uric Acid Reagent 2 X 67 mL + 1 X 54 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
10 | 05060500091521 | IR462-L | IR462-L | Uric Acid Enzyme Reagent 6 X 500 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
11 | 05060500091514 | IR461-L | IR461-L | Uric Acid Chromogen Reagent 6 X 1000 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
12 | 05060500091507 | IR460-911 | IR460-911 | Uric Acid Reagent 6 X 50 mL + 3 X 40 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
13 | 05060500091491 | IR460-WK | IR460-WK | Uric Acid Reagent 3 X 25 mL + 3 X 10 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
14 | 05060500091484 | IR460-X | IR460-X | Uric Acid Reagent 1 X 250 mL + 1 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
15 | 05060500091477 | IR460-R | IR460-R | Uric Acid Reagent 3 X 250 mL + 3 X 100 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
16 | 05055273209570 | UA8333 | URIC ACID (UA) | RANDOX LABORATORIES LIMITED | ||
17 | 05055273209563 | UA8069 | URIC ACID (UA) | RANDOX LABORATORIES LIMITED | ||
18 | 05055273206753 | UA7972 | URIC ACID (UA) | RANDOX LABORATORIES LIMITED | ||
19 | 04015630925124 | 5171857190 | 5171857190 | Uric Acid ver.2 | ROCHE DIAGNOSTICS GMBH | |
20 | 04015630922550 | 04657608190 | 04657608190 | Uric Acid ver.2 | ROCHE DIAGNOSTICS GMBH | |
21 | 04015630919154 | 3183807190 | 3183807190 | Uric Acid ver.2 | ROCHE DIAGNOSTICS GMBH | |
22 | 03610230007228 | 1300023870 | Yumizen C1200 Uric acid | HORIBA ABX SAS | ||
23 | 03610230005231 | 1220001670 | ABX PENTRA URIC ACID CP | HORIBA ABX SAS | ||
24 | EABA40000351 | 400-0035 | 400-0035 | The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry an The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement. | Piccolo BioChemistry Panel Plus | ABAXIS, INC. |
25 | EABA40000291 | 400-0029 | 400-0029 | The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total bilirubin, total protein, blood urea nitrogen (BUN), and uric acid in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used. | Piccolo General Chemistry 13 | ABAXIS, INC. |
26 | 00857969006518 | SA1025 | SA1025 | Uric Acid Reagent | ACE | ALFA WASSERMANN, INC. |
27 | 00857969006464 | RX1025 | RX1025 | Uric Acid Reagent | ACE | ALFA WASSERMANN, INC. |
28 | 00852169008263 | URA1500 | URA1500 | In Vitro Diagnostics testing kit R1:5X30mL | ClearChem Diagnostics Inc. Uric Acid | CLEARCHEM DIAGNOSTICS INC. |
29 | 00842768015519 | 10445145 | K1077 | Uric Acid Flex® reagent cartridge, 560 tests | Dimension Vista® Flex® reagent cartridge URCA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
30 | 00842768014192 | 10444967 | DF77 | Uric Acid Flex® reagent cartridge, 480 tests | Dimension® Flex® reagent cartridge URCA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
31 | 00817439021366 | UA600 | UA600 | For the quantitative determination of Uric Acid in serum using the Mindray BS-20 For the quantitative determination of Uric Acid in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only. 3 x 40ml. | MedTest DX Uric Acid for the BS200 | MEDTEST DX, INC. |
32 | 00817439021342 | UA480 | UA480 | For the quantitative determination of Uric Acid in serum using the Mindray BS-48 For the quantitative determination of Uric Acid in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. 4 x 40ml. | MedTest DX Uric Acid for the BS480 | MEDTEST DX, INC. |
33 | 00817302024555 | ST212 | ST212 | Uric Acid (URIC) Reagent | CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT ST212 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
34 | 00817302024418 | DT212 | DT212 | Uric Acid (URIC) Reagent | CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT DT212 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
35 | 00817302024258 | CC212 | CC212 | Uric Acid (URIC) | CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT CC212 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
36 | 00817302024173 | BL212 | BL212 | Uric Acid (URIC) | CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT BL212 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
37 | 00817302024074 | AU-212 | AU-212 | Uric Acid | CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT AU-212 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
38 | 00817274022191 | URI2-BUP | URIC ACID REAGENT PALS BULK (in 20 dry Liter bottles) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
39 | 00817274022184 | URI2-1L | URIC ACID LIQUID REAGENT (1x 1L) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
40 | 00817274022177 | DG-URI2-125 | URIC ACID LIQUID (2x 125mL + 1x 3mL Standard) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
41 | 00817274022160 | DG-URI2-1L | URIC ACID LIQUID (1 x 1 Liter + 1 x 5mL Standard) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
42 | 00817274022153 | URI2-BUL | URIC ACID LIQ BULK (in 20L cub) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
43 | 00817274022146 | XL-URI2-40 | URIC ACID LIQ (5x 40mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
44 | 00817274022139 | URI2-125 | URIC ACID LIQ (2x 125mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
45 | 00817274022122 | URI2-1LU | URIC ACID LIQ (1x 1L) Unlabeled Bottle | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
46 | 00817274022115 | URI2-125U | URIC ACID (1x 125mL) UV | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
47 | 00812137012050 | 500mL | 501-418 | For the quantitative determination of Uric Acid in serum. For in vitro diagnost For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout. Increased uric acid levels are also found in leukemia, polycythemia, familial idiopathic hyperuricemia, and conditions associated with decreased renal function. | Uric Acid Reagent | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
48 | 00811727016294 | 16-HU982-308 | 16-HU982-308 | Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 x 16ml R2. For the quantitative determination of uric acid in serum. For in vitro diagnostic use only. | Pointe Uric Acid Reagent | POINTE SCIENTIFIC, INC. |
49 | 00811727015990 | 14-U7581-160 | 14-U7581-160 | Pointe Uric Acid Reagent packaged for use on the Mindray BS480. 4 x 40ml. For Pointe Uric Acid Reagent packaged for use on the Mindray BS480. 4 x 40ml. For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. | Pointe Uric Acid Reagent | POINTE SCIENTIFIC, INC. |
50 | 00811727015136 | OU982-713 | OU982-713 | Pointe Scientific, Inc. Uric Acid Reagent is for the quantitative determination Pointe Scientific, Inc. Uric Acid Reagent is for the quantitative determination of Uric Acid in serum. Packaged for use on Olympus Analyzers. For in vitro diagnostic use only. 9 x 65ml, 8 x 16ml | Pointe Scientific, Inc. Uric Acid | POINTE SCIENTIFIC, INC. |