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 | 00857969006020 | ACI-32 | ACI-32 | Direct Total Iron-Binding Capacity (TIBC) Reagent | ACE | ALFA WASSERMANN, INC. |
2 | 00852169008232 | ITI1160 | ITI1160 | In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL | ClearChem Diagnostics Inc. TIBC-Direct | CLEARCHEM DIAGNOSTICS INC. |
3 | 00842768015465 | 10445134 | K3084 | Total Iron Binding Capacity Flex® reagent cartridge, 160 Tests | Dimension Vista® Flex® reagent cartridge TIBC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
4 | 00842768005756 | 10444944 | DF84 | Total Iron Binding Capacity Flex® reagent cartridge, 240 tests | Dimension® Flex® reagent cartridge IBCT | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00817439021267 | TIBC480 | TIBC480 | For use in the determination of total iron-binding capacity in serum on the Mind For use in the determination of total iron-binding capacity in serum on the Mindray BS-480 analyzer. For in vitro diagnostic use only.4 x 60ml, 4 x 36ml | Direct TIBC Reagent | MEDTEST DX, INC. |
6 | 00817302022704 | CC660 | CC660 | UIBC (Unsaturated Iron Binding Capacity) w/ cal 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
7 | 00816426021419 | KAI-302C | KAI-302C | For the calibration of the K-ASSAY® UIBC assay. | K-ASSAY® UIBC Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC |
8 | 00816426021402 | KAI-301 | KAI-301 | For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum. | K-ASSAY® UIBC Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC |
9 | 00816426021396 | KAI-300 | KAI-300 | For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum. | K-ASSAY® UIBC Reagent | KAMIYA BIOMEDICAL COMPANY, LLC |
10 | 00811727016263 | 16-I7517-400 | 16-I7517-400 | Pointe TIBC Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 8 x 20m Pointe TIBC Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 8 x 20ml R2. For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. | Pointe TIBC Reagent | POINTE SCIENTIFIC, INC. |
11 | 00811727015969 | 14-I7517-384 | 14-I7517-384 | Direct TIBC Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 36ml Direct TIBC Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 36ml R2. For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. | Pointe Direct TIBC Reagent | POINTE SCIENTIFIC, INC. |
12 | 00811727013057 | HI717-80 | HI717-80 | Direct TIBC Reagent is for use in the determination of total iron-binding capaci Direct TIBC Reagent is for use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. 1 x 60ml, 1 x 20ml | Pointe Scientific, Inc. Direct TIBC | POINTE SCIENTIFIC, INC. |
13 | 00811727012715 | HI717-120 | HI717-120 | Direct Total Iron-Binding Capacity (TIBC), for use in the determination of total Direct Total Iron-Binding Capacity (TIBC), for use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Size: 1 x 90mL, 1 x 30mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
14 | 00811727011640 | I7517-150 | I7517-150 | Reagent for use in the determination of total iron-binding capacity in serum on Reagent for use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. 1 x 90ml, 60ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
15 | 00630414595535 | 11097525 | 11097525 | Total Iron Binding Capacity ( TIBC) Atellica CH - RGT 800T | Atellica CH TIBC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
16 | 00630414474748 | 10309071 | 3940010 | IBCT - ADVIA Chem. - RGT - 4x100/4x80 tests | ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
17 | 00628063400959 | 153-50 | 153-50 | UIBC-SL | SEKISUI DIAGNOSTICS, LLC | |
18 | 00628063400942 | 153-30 | 153-30 | UIBC-SL | SEKISUI DIAGNOSTICS, LLC | |
19 | 00628063400935 | 153-90 | 153-90 | UIBC-SL | SEKISUI DIAGNOSTICS, LLC | |
20 | 00628063400928 | 153-10 | 153-10 | UIBC-SL | SEKISUI DIAGNOSTICS, LLC | |
21 | 00628063400638 | 102-25 | 102-25 | IRON (Total) | SEKISUI DIAGNOSTICS, LLC | |
22 | 00628063400621 | 102-15 | 102-15 | IRON (Total) | SEKISUI DIAGNOSTICS, LLC | |
23 | 00386100002190 | 10223-4 | 10223-4 | Iron Reagent Kit for use with EasyRA Analyzers | Iron (Fe) Reagent Kit | MEDICA CORPORATION |
24 | 15099590233365 | 467910 | 467910 | Iron Reagent (FE 2 x 200) | Synchron | BECKMAN COULTER, INC. |
25 | 15099590228729 | 465971 | 465971 | Total Iron Binding Capacity Reagent (IBCT 2 x 100) | Synchron | BECKMAN COULTER, INC. |
26 | 15099590222932 | 465976 | 465976 | SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit | Synchron | BECKMAN COULTER, INC. |
27 | 15099590011925 | OSR61205 | UIBC | AU | BECKMAN COULTER, INC. | |
28 | 10758750001873 | 6802001 | 6802001 | VITROS Chemistry Products dTIBC Reagent | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
29 | 07613336121597 | 08058776190 | 08058776190 | Unsaturated Iron-Binding Capacity | ROCHE DIAGNOSTICS GMBH | |
30 | 05060500091965 | IR150-1200 | IR150-1200 | UIBC Reagent 2 X 66 mL + 2 X 1 mL + 1 X 44 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
31 | 05060500091460 | IR152-L | IR152-L | UIBC Chromogen Reagent 6 X 250 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
32 | 05060500091453 | IR151-L | IR151-L | UIBC Binding Buffer Reagent 6 X 490 mL _ 6 X 10 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
33 | 05060500091446 | IR150-X | IR150-X | UIBC Reagent 1 X 245 mL + 1 X 5 mL + 1 X 80 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
34 | 05060500091439 | IR150-R | IR150-R | UIBC Reagent 3 X 245 mL + 3 X 5 mL + 3 X 80 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
35 | 05055273214734 | TI8375 | TI8375 | A TIBC_2 test system is a device intended for the quantitative in vitro determin A TIBC_2 test system is a device intended for the quantitative in vitro determination of total iron-binding capacity (TIBC) concentration in serum. | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED |
36 | 05055273214727 | TI4064 | TI4064 | A TIBC_2 test system is a device intended for the quantitative in vitro determin A TIBC_2 test system is a device intended for the quantitative in vitro determination of total iron-binding capacity (TIBC) concentration in serum. | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED |
37 | 05055273209495 | TI8331 | TOTAL-IRON BINDING CAPACITY (TIBC) | RANDOX LABORATORIES LIMITED | ||
38 | 05055273209488 | TI8065 | TI8065 | A TIBC test system is a device intended for the quantitative in vitro determinat A TIBC test system is a device intended for the quantitative in vitro determination of total iron-binding capacity (TIBC) concentration in serum. | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED |
39 | 05055273209433 | SI8330 | IRON (Fe) | RANDOX LABORATORIES LIMITED | ||
40 | 05055273209426 | SI8049 | IRON (Fe) | RANDOX LABORATORIES LIMITED | ||
41 | 05055273206517 | TI1010 | TOTAL-IRON BINDING CAPACITY (TIBC) | RANDOX LABORATORIES LIMITED | ||
42 | 05055273206227 | SI7967 | SI7967 | The product is intended for the quantitative in vitro determination of Iron in s The product is intended for the quantitative in vitro determination of Iron in serum and plasma | Fe | RANDOX LABORATORIES LIMITED |
43 | 05055273206210 | SI3821 | SI3821 | The product is intended for the quantitative in vitro determination of Iron in s The product is intended for the quantitative in vitro determination of Iron in serum and plasma | Fe | RANDOX LABORATORIES LIMITED |
44 | 05055273206203 | SI2818 | SI2818 | The product is an in vitro diagnostic test intended for the quantitative determi The product is an in vitro diagnostic test intended for the quantitative determination of Iron in serum | Fe | RANDOX LABORATORIES LIMITED |
45 | 05055273206197 | SI257 | SI257 | This product is intended for the quantitative in vitro determination of Iron in serum. | Fe | RANDOX LABORATORIES LIMITED |
46 | 05055273206180 | SI250 | SI250 | The product is intended for the quantitative in vitro determination of Iron/UIBC in serum. | UIBC | RANDOX LABORATORIES LIMITED |