No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740193867 | 06S6130 | 06S6130 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test | QKO | Reagent, coronavirus serological | Alinity | |
2 | 00380740193843 | 06S6120 | 06S6120 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test | QKO | Reagent, coronavirus serological | Alinity | |
3 | 00380740193829 | 06S6110 | 06S6110 | AdviseDx SARS-CoV-2 IgG II Control Kit | QKO | Reagent, coronavirus serological | Alinity | |
4 | 00380740193805 | 06S6101 | 06S6101 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | QKO | Reagent, coronavirus serological | Alinity | |
5 | 00380740193782 | 06S6030 | 06S6030 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
6 | 00380740193768 | 06S6020 | 06S6020 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
7 | 00380740193744 | 06S6010 | 06S6010 | AdviseDx SARS-CoV-2 IgG II Control Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
8 | 00380740112424 | 07K68-35 | 07K6835 | ARCHITECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
9 | 00380740112400 | 3P36-35 | 03P3635 | ARCHITECT AFP Reagent Kit | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
10 | 00380740105433 | 1L82-36 | 01L8236 | ARCHITECT AUSAB Reagent | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
11 | 00380740105426 | 1L82-26 | 01L8226 | ARCHITECT AUSAB Reagent | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
12 | 00380740105419 | 1L82-13 | 01L8213 | ARCHITECT AUSAB Controls | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
13 | 00380740105402 | 1L82-03 | 01L8203 | ARCHITECT AUSAB Calibrators | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
14 | 00380740081317 | 3P36-25 | 03P3625 | ARCHITECT AFP Reagent Kit | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
15 | 00380740081294 | 3P36-10 | 03P3610 | ARCHITECT AFP Controls | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
16 | 00380740081287 | 3P36-01 | 03P3601 | ARCHITECT AFP Calibrators | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
17 | 00380740014582 | 07K68-32 | 07K6832 | ARCHITECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
18 | 00380740014575 | 07K68-27 | 07K6827 | ARCHTECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
19 | 00380740014551 | 07K68-12 | 07K6812 | ARCHITECT CEA Controls | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
20 | 00380740014544 | 07K68-02 | 07K6802 | ARCHITECT CEA Calibrators | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
21 | 00380740013066 | 7D82-50 | 07D8250 | ARCHITECT Multi -Assay Manual Diluent | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
22 | 00380740009786 | 06E2365 | 06E2365 | ARCHITECT PRE TRIGGER SOLUTION | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
23 | 00380740009625 | 6C55-60 | 06C5560 | ARCHITECT TRIGGER SOLUTION | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
24 | 00380740009618 | 6C54-88 | 06C5488 | ARCHITECT CONCENTRATED WASH BUFFER (10L) | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
25 | 00380740009601 | 6C54-58 | 06C5458 | ARCHITECT CONCENTRATED WASH BUFFER | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
26 | 00380740009021 | 6C07-27 | 06C0727 | ARCHITECT Free PSA Reagent Kit | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
27 | 00380740009014 | 6C07-10 | 06C0710 | ARCHITECT Free PSA Controls | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
28 | 00380740009007 | 6C07-01 | 06C0701 | ARCHITECT Free PSA Calibrators | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
29 | 00380740008994 | 6C06-35 | 06C0635 | ARCHITECT Total PSA Reagent Kit | JJX,JJE,JIS,LTJ,MTF | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),ANALYZER, CHEMISTRY SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,CALIBRATOR, PRIMARY,PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER | 1 | ARCHITECT |
30 | 00380740008987 | 6C06-27 | 06C0627 | ARCHITECT Total PSA Reagent Kit | LTJ,JJX,JIS,JJE,MTF | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,SINGLE (SPECI PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),CALIBRATOR, PRIMARY,ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER | 1 | ARCHITECT |
31 | 00380740193720 | 06S6001 | 06S6001 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
32 | 00380740192167 | 06R8730 | 06R8730 | AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
33 | 00380740192099 | 06R9130 | 06R9130 | AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test | QKO | Reagent, coronavirus serological | Alinity | |
34 | 00380740192082 | 06R9120 | 06R9120 | AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test | QKO | Reagent, coronavirus serological | Alinity | |
35 | 00380740192075 | 06R9110 | 06R9110 | AdviseDx SARS-CoV-2 IgM Control Kit | QKO | Reagent, coronavirus serological | Alinity | |
36 | 00380740192068 | 06R9101 | 06R9101 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | QKO | Reagent, coronavirus serological | Alinity | |
37 | 00380740191863 | 06R8720 | 06R8720 | AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
38 | 00380740191856 | 06R8710 | 06R8710 | AdviseDx SARS-CoV-2 IgM Control Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
39 | 00380740191849 | 06R8701 | 06R8701 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
40 | 00380740174941 | 04V3831 | 04V3831 | Alinity i STAT CK-MB Reagent Kit 1000 Tests | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Alinity |
41 | 00380740174927 | 04V3821 | 04V3821 | Alinity i STAT CK-MB Reagent Kit 200 Tests | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Alinity |
42 | 00380740174910 | 04V3730 | 04V3730 | Alinity i STAT Myoglobin Reagent Kit 1000 Tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Alinity |
43 | 00380740174903 | 04V3720 | 04V3720 | Alinity i STAT Myoglobin Reagent Kit 200 Tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Alinity |
44 | 00380740172282 | 04V3710 | 04V3710 | Alinity i STAT Myoglobin Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Alinity |
45 | 00380740172275 | 04V3701 | 04V3701 | Alinity i STAT Myoglobin Calibrators | JIS | Calibrator, primary | 2 | Alinity |
46 | 00380740165505 | 04V3810 | 04V3810 | Alinity i STAT CK-MB Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Alinity |
47 | 00380740165482 | 04V3801 | 04V3801 | Alinity i STAT CK-MB Calibrators | JIS | Calibrator, primary | 2 | Alinity |
48 | 00380740158347 | 07P9331 | 07P9331 | Alinity i Free PSA Reagent Kit 1000 Tests | 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 | Alinity |
49 | 00380740158330 | 07P9321 | 07P9321 | Alinity i Free PSA Reagent Kit 200 Tests | 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 | Alinity |
50 | 00380740158323 | 07P9231 | 07P9231 | Alinity i Total PSA Reagent Kit 1200 Tests | MTF | Total, prostate specific antigen (noncomplexed & complexed) for detection of pro Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer | 3 | Alinity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07613336198919 | 09108912190 | 09108912190 | Vitamin D total G3 CC 5 Elecsys | CalCheck Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
2 | 07613336198261 | 09077871190 | 09077871190 | Elecsys FT3 III CalSet | ROCHE DIAGNOSTICS GMBH | |
3 | 07613336179918 | 09211888001 | 09211888001 | cobas pro SBL e 801 | ROCHE DIAGNOSTICS GMBH | |
4 | 07613336179550 | 09205730001 | 09205730001 | cobas pro Transport Belt | ROCHE DIAGNOSTICS GMBH | |
5 | 07613336179543 | 09205721001 | 09205721001 | cobas pro Transport Belt | ROCHE DIAGNOSTICS GMBH | |
6 | 07613336179536 | 09205713001 | 09205713001 | cobas pro Transport Belt (2 AU, 2 ISE) | ROCHE DIAGNOSTICS GMBH | |
7 | 07613336179529 | 09205691001 | 09205691001 | cobas pro SBL c 503 | ROCHE DIAGNOSTICS GMBH | |
8 | 07613336179512 | 09205683001 | 09205683001 | cobas pro transport line | ROCHE DIAGNOSTICS GMBH | |
9 | 07613336179505 | 09205675001 | 09205675001 | cobas pro SB | ROCHE DIAGNOSTICS GMBH | |
10 | 07613336179499 | 09205632001 | 09205632001 | cobas pro SSU | ROCHE DIAGNOSTICS GMBH | |
11 | 07613336172674 | 09038124190 | 09038124190 | Vitamin D total G2 PC Elecsys V2 | PreciControl Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
12 | 07613336171769 | 09013296190 | 09013296190 | Elecsys HCG STAT CalSet II | ROCHE DIAGNOSTICS GMBH | |
13 | 07613336169520 | 07679874190 | 07679874190 | CalCheck Androstenedione | ROCHE DIAGNOSTICS GMBH | |
14 | 07613336167496 | 08838534160 | 08838534160 | total PSA CalSet II | ROCHE DIAGNOSTICS GMBH | |
15 | 07613336166000 | 08791716160 | 08791716160 | Elecsys total PSA | ROCHE DIAGNOSTICS GMBH | |
16 | 07613336165997 | 08791686160 | 08791686160 | Elecsys total PSA | ROCHE DIAGNOSTICS GMBH | |
17 | 07613336165980 | 08791732190 | 08791732190 | Elecsys total PSA | ROCHE DIAGNOSTICS GMBH | |
18 | 07613336164358 | 08740062160 | 08740062160 | PreciControl Maternal Care | ROCHE DIAGNOSTICS GMBH | |
19 | 07613336159095 | 08463689001 | 08463689001 | cobas pro Sample Buffer | ROCHE DIAGNOSTICS GMBH | |
20 | 07613336158876 | 08464537001 | 08464537001 | cobas pro ISE analytical unit | ROCHE DIAGNOSTICS GMBH | |
21 | 07613336158852 | 08464502001 | 08464502001 | cobas pro Sample Supply Unit | ROCHE DIAGNOSTICS GMBH | |
22 | 07613336158821 | 08463743001 | 08463743001 | cobas pro c 503 SBL - DL | ROCHE DIAGNOSTICS GMBH | |
23 | 07613336158807 | 08463727001 | 08463727001 | cobas pro c 503 SBL-TL | ROCHE DIAGNOSTICS GMBH | |
24 | 07613336158784 | 08463662001 | 08463662001 | cobas c 503 analytical unit | ROCHE DIAGNOSTICS GMBH | |
25 | 07613336158654 | 08462984001 | 08462984001 | cobas pro e 801 SBL-DL | ROCHE DIAGNOSTICS GMBH | |
26 | 07613336158562 | 08459606001 | 08459606001 | cobas e 801 Immunoassay analyzer | ROCHE DIAGNOSTICS GMBH | |
27 | 07613336158456 | 08454345001 | 08454345001 | cobas e 801 Immunoassay analyzer | ROCHE DIAGNOSTICS GMBH | |
28 | 07613336154380 | 04485220160 | 04485220160 | Total PSA G2 CS Elecsys V2.1 | total PSA Calset II | ROCHE DIAGNOSTICS GMBH |
29 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | Elecsys tPSA | ROCHE DIAGNOSTICS GMBH |
30 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | Elecsys tPSA | ROCHE DIAGNOSTICS GMBH |
31 | 07613336154243 | 08362785190 | 08362785190 | Control Set ß2Microglobulin | ROCHE DIAGNOSTICS GMBH | |
32 | 07613336143162 | 08133859190 | 08133859190 | ?-CrossLaps CalCheck 5 | ROCHE DIAGNOSTICS GMBH | |
33 | 07613336143155 | 07475993190 | 07475993190 | CalCheck IGF-1 | ROCHE DIAGNOSTICS GMBH | |
34 | 07613336142714 | 07574797190 | 07574797190 | CalCheck IGFBP-3 | ROCHE DIAGNOSTICS GMBH | |
35 | 07613336142578 | 08126232001 | 08126232001 | Self-Contained ISE Support Box | ROCHE DIAGNOSTICS GMBH | |
36 | 07613336129203 | 07464258190 | 07464258190 | Vitamin D total II CalCheck 5 | ROCHE DIAGNOSTICS GMBH | |
37 | 07613336120392 | 08047545190 | 08047545190 | Calibrator ß2Microglobulin | ROCHE DIAGNOSTICS GMBH | |
38 | 07333066022314 | 34-2317-94 | 34-2317-94 | Phadia Maintenance Solution Large | Phadia Maintenance Solution Large | PHADIA AB |
39 | 07333066022307 | 34-2317-93 | 34-2317-93 | Phadia Maintenance Solution Small | Phadia Maintenance Solution Small | PHADIA AB |
40 | 07333066000985 | 10-9537-01 | 10-9537-01 | Contains eight ampules of Maintenance Concentrate for use with Phadia instruments. | Maintenance Solution Kit Large | PHADIA AB |
41 | 07333066000633 | 10-9476-01 | 10-9476-01 | Contains ten ampoules of Maintenance Concentrate, one vial of Anti-Foam and one Contains ten ampoules of Maintenance Concentrate, one vial of Anti-Foam and one package of CheckCAP for use with Phadia instruments. | Maintenance Solution Kit | PHADIA AB |
42 | 07332699000461 | Calibrator | P000057 | Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Glucose, Lactate, Pyruvate, Glycerol and Glutamate. | Calibrator A | M DIALYSIS INC. |
43 | 07070060014722 | 1116792 | 1116792 | HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert. | Afinion HbA1c Calibration Verification | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
44 | 07070060014661 | 1116975 | 1116975 | HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 C HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 Control C II, 1 package insert. | Afinion HbA1c Control | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
45 | 07070060006505 | 1115178 | 1115178 | HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. Content: 1 Control C1. 1 Control C II. 1 package insert. DI covers Alere Afinion HbA1c Control and Afinion HbA1c Control. | Alere Afinion HbA1c Control | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
46 | 06945040104667 | BC3000 | Automatic Biochemistry Analyzer | CONTEC | CONTEC MEDICAL SYSTEMS CO., LTD. | |
47 | 06438115000112 | 145217 | 145217 | QuikRead go® CRP Control Set is intended for use as assayed quality-control mate QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go CRP assay with the QuikRead go Instrument. | QuikRead go® CRP Control set | AIDIAN OY |
48 | 06438115000105 | 145216 | 145216 | QuikRead go® CRP Verification Set is designed to be used for calibration verific QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. It is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. | QuikRead go® CRP Verification set | AIDIAN OY |
49 | 05999883586891 | Pictus 400 clinical chemistry analyzer W/out ISE | P400-1 | A discrete photometric chemistry analyzer for clinical use is a device intended A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units. | Pictus 400 Clinical chemistry analyzer | DIATRON MEDICINAI INSTRUMENTUMOK LABORATORIUMI DIAGNOSZTIKAI FEJLESZTO-GYARTO ZARTKORUEN MUKODO RESZVENYTARSASAG |
50 | 05999883586884 | Pictus 700 clinilcal chemistry analyzer W/out ISE | P700-1 | A discrete photometric chemistry analyzer for clinical use is a device intended A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units. | Pictus 700 clinilcal chemistry analyzer | DIATRON MEDICINAI INSTRUMENTUMOK LABORATORIUMI DIAGNOSZTIKAI FEJLESZTO-GYARTO ZARTKORUEN MUKODO RESZVENYTARSASAG |