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 | 00812242030697 | HBVH202 | HBVH202 | HBV 1E6 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
2 | 00812242030680 | HBVL201 | HBVL201 | HBV 1E3 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
3 | 00812242030673 | HBVP200 | HBVP200 | HBV Verification Panel 1.4mL | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
4 | 00812242030659 | HCVH202 | HCVH202 | HCV 1E6 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
5 | 00812242030642 | HCVL201 | HCVL201 | HCV 1E3 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
6 | 00812242030635 | HCVP200 | HCVP200 | HCV Verification Panel 1.4mL | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
7 | 00812242030611 | CMVH202 | CMVH202 | CMV 5E5 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
8 | 00812242030604 | CMVL201 | CMVL201 | CMV 1E3 IU/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
9 | 00812242030598 | CMVP200 | CMVP200 | CMV Verification Panel 1.4mL | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
10 | 00812242030574 | HIVH202 | HIVH202 | HIV-1 1E5 cp/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
11 | 00812242030567 | HIVL201 | HIVL201 | HIV-1 1E3 cp/mL Precision | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
12 | 00812242030550 | HIVP200 | HIVP200 | HIV-1 Verification Panel 1.4mL | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
13 | 00812242030529 | JCVP100 | JCVP100 | JCV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
14 | 00812242030475 | B19P100 | B19P100 | Parvovirus B19 Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
15 | 00812242030444 | HSV2P100 | HSV2P100 | HSV-2 Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
16 | 00812242030413 | HSV1P100 | HSV1P100 | HSV-1 Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
17 | 00812242030383 | HV6BP100 | HV6BP100 | HHV-6B Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
18 | 00812242030376 | HV6AP100 | HV6AP100 | HHV-6A Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
19 | 00812242030345 | VZVP100 | VZVP100 | VZV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
20 | 00812242030314 | ADVP100 | ADVP100 | Adenovirus Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
21 | 00812242030284 | ZKVP100 | ZKVP100 | Zika Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
22 | 00812242030222 | HBVAMR | HBVAMR | HBV Analytical Measurement Range Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
23 | 00812242030215 | HCVAMR | HCVAMR | HCV Analytical Measurement Range Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
24 | 00812242030208 | HIVAMR | HIVAMR | HIV-1 Analytical Measurement Range Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
25 | 00812242030178 | BKVP100 | BKVP100 | BKV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
26 | 00812242030147 | EBVP100 | EBVP100 | EBV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
27 | 00812242030116 | HBVP100 | HBVP100 | HBV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
28 | 00812242030086 | HCVP100 | HCVP100 | HCV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
29 | 00812242030031 | CMVP100 | CMVP100 | CMV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
30 | 00812242030000 | HIVP100 | HIVP100 | HIV-1 Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
31 | 00812137012173 | 2 x 2mL | 502-157 | For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens. | TIBC Calibrator Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
32 | 00811727011893 | M7562-CAL | M7562-CAL | Pointe Scientific, Inc. Microalbumin Calibrator is intended to be used for the c Pointe Scientific, Inc. Microalbumin Calibrator is intended to be used for the calibration of Pointe Scientific’s Microalbumin immunoturbidimetric assay for quantitating albumin in urine specimens. For in vitro diagnostic use. | Pointe Scientific, Inc. Microalbumin Calibrator | POINTE SCIENTIFIC, INC. |
33 | 00811727011886 | M7562-100 | M7562-100 | Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use.4 x 20 ml., 2 x 10 ml. | Pointe Scientific, Inc. Microalbumin | POINTE SCIENTIFIC, INC. |
34 | 00811727011657 | I7517-CAL | I7517-CAL | Reagent for calibrating the quantitative Direct Total Iron-Binding Capacity (TIB Reagent for calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. 2 x 1.0ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
35 | 00657498000854 | 2360-401 | 2360-401 | Stanbio Glycated Serum Protein (GSP) Calibrator Kit is intended to be used for c Stanbio Glycated Serum Protein (GSP) Calibrator Kit is intended to be used for calibration of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062). | Glycated Serum Protein Calibrator Set | STANBIO LABORATORY, L.P. |
36 | 00630414948775 | 10712611 | KC638 | Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL; 2D x 1.0 mL; Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL; 2D x 1.0 mL; 2E x 1.0 mL; 2F x 1.0 mL) | Dimension Vista® Testosterone Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
37 | 00630414948768 | 10712610 | KC637 | Progesterone Calibrator, 10 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL;2D x 1.0 mL; Progesterone Calibrator, 10 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL;2D x 1.0 mL; 2E x 1.0 mL) | Dimension Vista® PROG Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
38 | 00630414948492 | 10716280 | DC18C | Chemistry I Calibrator, 2x3x2mL | Dimension® CHEM I CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
39 | 00630414610870 | 11537241 | 11537241 | LDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL | Atellica CH LDLC CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
40 | 00630414607047 | 11417772 | KC872 | DV/DM COV2G/CV2G CAL | DV/DM COV2G/CV2G CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
41 | 00630414603407 | 10997192 | 10997192 | ADVIA Centaur Sex Hormone Binding Globulin Calibrator (SHBG CAL) Set - 2x2x2mL - 2PK | ADVIA Centaur® CAL SHBG | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
42 | 00630414601199 | 10916060 | 10916060 | ALP 2 - ADVIA Chem. - CAL - 6x1x1mL | ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00630414600451 | 10995629 | 10995629 | Insulin (IRI) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 1.0mL | Atellica IM IRI Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
44 | 00630414600420 | 10995542 | 10995542 | C-Peptide (CpS) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 5.0mL | Atellica IM CpS Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
45 | 00630414600338 | 10995720 | 10995720 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 500T | Atellica™ IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
46 | 00630414600321 | 10995719 | 10995719 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 100T | Atellica™ IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00630414599861 | 10995673 | 10995673 | Sex Hormone Binding Globulin (SHBG) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL | Atellica IM SHBG Calibrator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00630414598246 | 10995497 | 10995497 | Calibrator 80 Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL | Atellica IM Calibrator 80 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00630414598239 | 10995496 | 10995496 | Calibrator 30 Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL | Atellica IM Calibrator 30 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00630414598222 | 10995495 | 10995495 | Calibrator 30 Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL | Atellica IM Calibrator 30 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |