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 | B24211TESHUE010 | 11-TESHU-E01 | 11-TESHU-E01 | Intended for the direct quantitative determination of Testosterone by an enzyme Intended for the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. | Serum Testosterone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
2 | B24211FTEHUE010 | 11-FTEHU-E01 | 11-FTEHU-E01 | For the direct quantitative determination of Free Testosterone by an enzyme immu For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. | Free Testosterone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
3 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | FastPack® IP Testo Kit (90) | QUALIGEN INC. |
4 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | FastPack® IP SHBG | QUALIGEN INC. |
5 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | FastPack® IP Testo Kit (30) | QUALIGEN INC. |
6 | 15099590231347 | 33560 | 33560 | The Access Testosterone assay is a paramagnetic particle, chemiluminescent immun The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. | Access Testosterone | BECKMAN COULTER, INC. |
7 | 15099590231293 | 33565 | 33565 | The Access Testosterone Calibrators are intended to calibrate the Access Testost The Access Testosterone Calibrators are intended to calibrate the Access Testosterone assay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. | Access Testosterone Calibrator | BECKMAN COULTER, INC. |
8 | 15099590204037 | A48617 | A48617 | The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay f The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. | Access SHBG | BECKMAN COULTER, INC. |
9 | 14560189213354 | N/A | ST AIA-PACK SHBG | TOSOH CORPORATION | ||
10 | 14560189210032 | N/A | ST AIA-PACK Testosterone | TOSOH CORPORATION | ||
11 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | FastPack® IP SHBG | QUALIGEN INC. |
12 | 10816467020034 | Testo Immunoassay | 25000009 | 50 Test Non-Ported Testo Immunoassay Kit | FastPack® Testo Kit (50) | QUALIGEN INC. |
13 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
14 | 08809317540375 | FRTE-AP | FRTEAP 020 | It is used for the quantitative measurement of Total Testosterone in human serum It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample. | FREND | NANOENTEK, INC. |
15 | 08809317540153 | FREND Testosterone | FRTE 020 | It is used for the quantitiative determination of Testosterone in human specimen It is used for the quantitiative determination of Testosterone in human specimen using FREND System. | FREND | NANOENTEK, INC. |
16 | 07613336170571 | 08946370190 | 08946370190 | Testosterone G2 Elecsys E2G 300 V2 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH |
17 | 07613336170557 | 08946353190 | 08946353190 | Testosterone G2 Elecsys cobas e 100 V2 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH |
18 | 05060169691322 | IS-5600 | IDS SHBG | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
19 | 04560189213388 | N/A | AIA-PACK SHBG CONTROL SET | TOSOH CORPORATION | ||
20 | 04560189213371 | N/A | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
21 | 04560189211346 | N/A | ST AIA-PACK Testosterone SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
22 | 04560189211339 | N/A | ST AIA-PACK Testosterone CALIBRATOR SET | TOSOH CORPORATION | ||
23 | 04049325006546 | RE62039. | RE62039. | Testosterone Luminescence Immunoassay - 10 x 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |
24 | 04049325003545 | RE62031 | RE62031 | Testosterone Luminescence Immunoassay - 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |
25 | 04015630940516 | 07258496190 | 07258496190 | Elecsys SHBG | ROCHE DIAGNOSTICS GMBH | |
26 | 04015630939817 | 07027915190 | 07027915190 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH | |
27 | 04015630939312 | 05200067160 | 05200067160 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH | |
28 | 04015630939305 | 3052001160 | 03052001160 | Elecsys SHBG | ROCHE DIAGNOSTICS GMBH | |
29 | 00850392007152 | BC-1115 | BC-1115 | The BioCheck Testosterone EIA Test Kit is intended for the quantitative determin The BioCheck Testosterone EIA Test Kit is intended for the quantitative determination of testosterone concentration in human serum. | BioCheck Testosterone EIA Test Kit | BIOCHECK, INC. |
30 | 00850039602276 | 1 Universal | 635 | Stopping Solution EIA 1 - 15mL | Pantex Universal | PANTEX |
31 | 00850039602269 | 1 Universal | 635 | Color Development Reagent EIA 1 - 15mL | Pantex Universal | PANTEX |
32 | 00850039602252 | P635ST | 635 | Salivary Testosterone EIA Assay Diluent | Pantex P635ST | PANTEX |
33 | 00850039602245 | P635ST | 635 | Salivary Testosterone EIA Conjugate Buffer | Pantex P635ST | PANTEX |
34 | 00850039602238 | P635ST | 635 | Salivary Testosterone EIA Antibody | Pantex P635ST | PANTEX |
35 | 00850039602221 | P635ST | 635 | Salivary Testosterone EIA HRP Enzyme | Pantex P635ST | PANTEX |
36 | 00850039602214 | P635ST | 635 | Salivary Testosterone EIA Stock Control (20,000 pg/mL) | Pantex P635ST | PANTEX |
37 | 00850039602207 | P635ST | 635 | Salivary Testosterone EIA Stock Calibrator (62,500 pg/mL) | Pantex P635ST | PANTEX |
38 | 00842768026485 | 10488399 | K6465 | LOCI Total Testosterone Flex® reagent cartridge, 320 tests | Dimension Vista® Total Testosterone Flex® Reagent Cartridge | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
39 | 00840239061010 | EIA-6101 | EIA-6101 | The device is an Enzyme Immunoassay (EIA) for the quantitative measurement of fr The device is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone in human serum. s and adrogenital syndromes. | Free Testosterone ELISA | DRG INTERNATIONAL INC |
40 | 00840239046383 | EIA-4638 | EIA-4638 | For the direct quantitative determination of Free Testosterone by enzyme immunoa For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only. | Free Testosterone ELISA | DRG INTERNATIONAL INC |
41 | 00816870022963 | 5375-300 | 5375-300B | Monobind AccuLite Free Testosterone CLIA Kit - 192 Wells | MONOBIND, INC. | |
42 | 00816870022956 | 5375-300 | 5375-300A | Monobind AccuLite Free Testosterone CLIA Kit - 96 Wells | MONOBIND, INC. | |
43 | 00816870022949 | 3775-300 | 3775-300B | Monobind AccuLite Testosterone CLIA Kit - 192 Wells | MONOBIND, INC. | |
44 | 00816870022932 | 3775-300 | 3775-300A | Monobind AccuLite Testosterone CLIA Kit - 96 Wells | MONOBIND, INC. | |
45 | 00816870022925 | 9175-300 | 9175-300B | Monobind AccuLite SHBG CLIA Kit - 192 Wells | MONOBIND, INC. | |
46 | 00816870022918 | 9175-300 | 9175-300A | Monobind AccuLite SHBG CLIA Kit - 96 Wells | MONOBIND, INC. | |
47 | 00816870021522 | 5325-300 | 5325-300B | Monobind AccuBind Free Testosterone ELISA Kit - 192 Wells | MONOBIND, INC. | |
48 | 00816870021515 | 5325-300 | 5325-300A | Monobind AccuBind Free Testosterone ELISA Kit - 96 Wells | MONOBIND, INC. | |
49 | 00816870021508 | 3725-300 | 3725-300B | Monobind AccuBind Testosterone ELISA Kit - 192 Wells | MONOBIND, INC. | |
50 | 00816870021492 | 3725-300 | 3725-300A | Monobind AccuBind Testosterone ELISA Kit - 96 Wells | MONOBIND, INC. |