| 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 | 07613336133644 | 08105596190 | 08105596190 | Tina-quant Cystatin C Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 2 | 07090038460122 | 1030 | The Gentian Cystatin C Controls are intended to be used to evaluate the quality The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay. | Gentian Cystatin C Single Use Control High | GENTIAN AS | |
| 3 | 07090038460115 | 1029 | The Gentian Cystatin C Controls are intended to be used to evaluate the quality The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay. | Gentian Cystatin C Single Use Control Low | GENTIAN AS | |
| 4 | 07090038460108 | 1051 | The Gentian Cystatin C Calibrator kit is intended to be used to establish a cali The Gentian Cystatin C Calibrator kit is intended to be used to establish a calibration curve for measuring Cystatin C concentration in human serum or plasma with the Gentian Cystatin C Immunoassay. | Gentian Cystatin C Calibrator Kit | GENTIAN AS | |
| 5 | 07090038460092 | 1012 | The Gentian Cystatin C Calibrator is intended to be used to establish a calibrat The Gentian Cystatin C Calibrator is intended to be used to establish a calibration curve for measuring Cystatin C concentration in human serum or plasma with the Gentian Cystatin C Immunoassay. | Gentian Cystatin C Calibrator | GENTIAN AS | |
| 6 | 07090038460085 | 1026 | The Gentian Cystatin C Controls are intended to be used to evaluate the quality The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay. | Gentian Cystatin C Control Kit (2 x 5mL) | GENTIAN AS | |
| 7 | 07090038460078 | 1019 | The Gentian Cystatin C Controls are intended to be used to evaluate the quality The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay. | Gentian Cystatin C Control Kit (2 x 1mL) | GENTIAN AS | |
| 8 | 07090038460061 | 1101 | Gentian Cystatin C Reagent Kit | GENTIAN AS | ||
| 9 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 10 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 11 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 12 | 05055273208665 | CYS4004 | CYS4004 | The device is intended for the quantitative in vitro determination of Cystatin C The device is intended for the quantitative in vitro determination of Cystatin C in serum or plasma. | CYSC | RANDOX LABORATORIES LIMITED |
| 13 | 05051700017909 | LK048.OPT.A | Optilite Cystatin C Kit | THE BINDING SITE GROUP LIMITED | ||
| 14 | 05051700011624 | LK048.S | Human Cystatin C Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | ||
| 15 | 04560189212206 | N/A | ST AIA-PACK Cyctatin C Sample Dilting Solution | TOSOH CORPORATION | ||
| 16 | 04015630932405 | 6600263190 | 6600263190 | Tina-quant Cystatin C Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 17 | 04015630932399 | 6600239190 | 6600239190 | Tina-quant Cystatin C Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 18 | 04015630932382 | 6600174190 | 6600174190 | Tina-quant Cystatin C Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 19 | 00842768007934 | 10446116 | OQNM13 | Quantitative determination of cystatin C in human serum and heparinized plasma o Quantitative determination of cystatin C in human serum and heparinized plasma on BN Systems | N Latex Cystatin C | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 20 | 00842768006104 | 10445895 | K7040 | For the quantitative measurement of cystatin C in human serum and plasma on the For the quantitative measurement of cystatin C in human serum and plasma on the Dimension Vista® System | DImension Vista® Cystatin C Flex® reagent cartridge | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 21 | 00817302020069 | CC691 | CC691 | CYST (Cystatin-C) 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 22 | 00816426020320 | KAI-074 | KAI-074 | For the quantitative determination of human cystatin C in serum, EDTA plasma, or For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. | K-ASSAY® Cystatin C Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC |
| 23 | 00816426020313 | KAI-073 | KAI-073 | For the quantitative determination of human cystatin C in serum, EDTA plasma, or For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. | K-ASSAY® Cystatin C Reagent | KAMIYA BIOMEDICAL COMPANY, LLC |
| 24 | 00630414595573 | 11097636 | 11097636 | Cystatin C (CysC) Atellica™ CH - RGT 800T | Atellica™ CH CysC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 25 | 00630414557915 | 10361930 | 4851534 | Cystatin C - ADVIA Chem. - RGT - 4x100 tests | ADVIA® Chemistry CYSC Cystatin-C Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 26 | 00630414236919 | 11097647 | 11097647 | Cystatin C_2 (CYSC_2) Atellica CH - RGT 800T | Atellica CH CYSC_2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 27 | 00630414224916 | 10734503 | 10734503 | ADVIA Chemistry Cystatin C_2 Assay | ADVIA Chemistry Cystatin C_2 Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 28 | 00630414167824 | 10873631 | OQNM19 | Quantitative determination of cystatin C in human serum and lithium-heparinized Quantitative determination of cystatin C in human serum and lithium-heparinized plasma on BN Systems | N Latex Cystatin C | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 29 | 17090038460020 | 1019 / A52765 | Gentian Cystatin C Control Kit (2 x 1mL) | GENTIAN AS | ||
| 30 | 17090038460013 | 1103 / B08179 | Gentian Cystatin C Reagent for the Beckman Coulter AU Systems (1x300) | GENTIAN AS | ||
| 31 | 17090038460051 | 1100 / A52761 | Gentian Cystatin C Reagent Beckman Coulter UDR Kit | GENTIAN AS | ||
| 32 | 17090038460037 | 1051 / A52763 | Gentian Cystatin C Calibrator Kit | GENTIAN AS | ||
| 33 | 14560189212173 | N/A | ST AIA-PACK Cystatin C | TOSOH CORPORATION |