| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 14560189212463 | N/A | LCP | Assay, Glycosylated Hemoglobin | ST AIA-PACK HbA1c | |||
| 2 | 14560189212135 | N/A | KHQ | Radioassay, Triiodothyronine Uptake | ST AIA-PACK T-U | |||
| 3 | 14560189212005 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK RBC FOLATE | |||
| 4 | 04560189211827 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | AIA-PACK PRL CALIBRATOR SET | ||
| 5 | 04560189211407 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI CALIBRATOR SET | ||
| 6 | 04560189211292 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Sample Diluting Solution | ||
| 7 | 04560189212299 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK bHCG Calibration Verification Test Set | ||
| 8 | 04560189212022 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK RBC FOLATE HEMOLYZING REAGENT SET | ||
| 9 | 14560189212739 | N/A | CHP | Radioimmunoassay, Estradiol | ST AIA-PACK hsE2 | |||
| 10 | 14560189212517 | N/A | CKG | Radioimmunoassay, Acth | ST AIA-PACK ACTH | |||
| 11 | 14560189212104 | n/a | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | ST AIA-PACK PA | |||
| 12 | 14560189211916 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK Folate | |||
| 13 | 04560189211940 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK Floate Sample Diluting Solution | ||
| 14 | 14560189211879 | N/A | CDD | Radioassay, Vitamin B12 | AIA-PACK B12 | |||
| 15 | 04560189211889 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Calibrator Set | ||
| 16 | 04560189211650 | N/A | CEP | Radioimmunoassay, Luteinizing Hormone | 1 | ST AIA-PACK LH II CALIBRATOR SET | ||
| 17 | 04560189211445 | N/A | CFL | Radioimmunoassay, Human Growth Hormone | 1 | AIA-PACK HGH Calibrator Set | ||
| 18 | 04560189211391 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI SAMPLE DILUTING SOLUTION | ||
| 19 | 04560189211308 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Calibrator Set | ||
| 20 | 14560189210834 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | ST AIA-PACK PRL | |||
| 21 | 14560189210483 | N/A | DBF | Ferritin, Antigen, Antiserum, Control | ST AIA-PACK FER | |||
| 22 | 14560189210391 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | ST AIA-PACK FSH | |||
| 23 | 14560189210360 | N/A | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | ST AIA-PACK TSH | ||
| 24 | 14560189210285 | N/A | CDP | Radioimmunoassay, Total Triiodothyronine | ST AIA-PACK FT3 | |||
| 25 | 14560189210117 | N/A | MMI | Immunoassay Method, Troponin Subunit | ST AIA-PACK cTnI 2 | |||
| 26 | 04560189212817 | N/A | LPS | Urinary Homocystine (Nonquantitative) Test System | 2 | ST AIA-PACK Homocysteine Pretreatment Set | ||
| 27 | 04560189212800 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK Homocysteine Control Set | ||
| 28 | 04560189212596 | N/A | JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | ST AIA-PACK DHEA-S Sample Diluting Solution | ||
| 29 | 04560189212190 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Cystatin C Calibatator Set | ||
| 30 | 04560189211285 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | ST AIA-PACK E2 CALIBRATOR SET | ||
| 31 | 04560189211278 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | AIA-PACK E2 Sample Diluting Solution | ||
| 32 | 04560189211148 | N/A | LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | AIA-PACK CA 125 Calibrator Set | ||
| 33 | 04560189211124 | N/A | NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pa System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 | AIA-PACK CA 19-9 Sample Diluting Solution | ||
| 34 | 04560189211100 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | 2 | AIA-PACK 27.29 Calibrator Set | ||
| 35 | 14560189212173 | N/A | NDY | Test, Cystatin C | ST AIA-PACK Cystatin C | |||
| 36 | 04560189211902 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Sample Diluting Solution | ||
| 37 | 04560189211780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | 2 | AIA-PACK CEA Sample Diluting Solution | ||
| 38 | 04560189211421 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Intact PTH CALIBRATOR SET | ||
| 39 | 04560189211414 | N/A | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION | ||
| 40 | 04560189211353 | N/A | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | AIA-PACK βHCG Calibrator Set | ||
| 41 | 14560189210780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | ST AIA-PACK CEA | |||
| 42 | 14560189213125 | N/A | MRG | System, Test, Vitamin D | ST AIA-PACK 25-OH Vitamin D | |||
| 43 | 14560189210179 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | ST AIA-PACK 27.29 | |||
| 44 | 14560189210155 | N/A | DGC | Ige, Antigen, Antiserum, Control | ST AIA-PACK IgEII | |||
| 45 | 04560189284005 | N/A | KHO | Fluorometer, For Clinical Use | 1 | 9tray Sorter | ||
| 46 | 04560189283619 | N/A | LCP | Assay, Glycosylated Hemoglobin | 2 | G8 Variant Elution Buffer HSi No.2 (S) | ||
| 47 | 04560189213395 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK PROG II CALIBRATOR SET | ||
| 48 | 04560189213371 | N/A | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | ||
| 49 | 04560189213333 | N/A | JIT | Calibrator, Secondary | 2 | AIA-PACK C-Peptide II Calibrator Set | ||
| 50 | 04560189213135 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 30014613802211 | 20221R | 20221R | Sofia Analyzer, Reconditioned | Sofia | QUIDEL CORPORATION |
| 2 | 30014613338109 | 94600 | 94600 | Triage TOX Drug Screen, 94600 | Triage | QUIDEL CARDIOVASCULAR INC. |
| 3 | 30014613337164 | 55071 | 55071 | Triage MeterPro, International | Triage | QUIDEL CARDIOVASCULAR INC. |
| 4 | 30014613337157 | 55070 | 55070 | Triage MeterPro, North America | Triage | QUIDEL CARDIOVASCULAR INC. |
| 5 | 30014613336648 | 20299R | 20299R | Sofia Analyzer | Sofia | QUIDEL CORPORATION |
| 6 | 30014613336341 | 20299 | 20299 | Sofia Analyzer | Sofia | QUIDEL CORPORATION |
| 7 | 30014613202219 | 20221 | 20221 | Sofia Analyzer | Sofia | QUIDEL CORPORATION |
| 8 | 10758750011308 | 6801059B | 6801059B | VITROS ECI IMMUNODIAGNOSTIC SYSTEM - Refurbished - Box B | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 9 | 10758750001040 | 6801059 | 6801059 | VITROS ECI IMMUNODIAGNOSTIC SYSTEM - Refurbished | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 10 | 10758750000272 | 1922814 | 1922814 | VITROS ECiQ Immunodiagnostic System | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 11 | 10627966005244 | C3100 | RAMP® 200 TM Test Module | RESPONSE BIOMEDICAL CORP | ||
| 12 | 10627966005237 | C2100 | RAMP® 200 CM Control Module | RESPONSE BIOMEDICAL CORP | ||
| 13 | 10627966005220 | C1100 | RAMP® 1 Clinical Reader System | RESPONSE BIOMEDICAL CORP | ||
| 14 | 09120052070521 | 30050303 01 | 30050303 | microplate reader | INFINITE 200 PRO | TECAN AUSTRIA GMBH |
| 15 | 08809317540207 | FREND System | F10 | FREND System is designed for reding the FREND cartridge of a quantitative. | FREND | NANOENTEK, INC. |
| 16 | 08806133070437 | AFIAS-TSHCAL | Boditech TSH Calibrator | BODITECH MED INC. | ||
| 17 | 08806133060353 | AFIAS-TSHCLT | Boditech TSH Control | BODITECH MED INC. | ||
| 18 | 08806133010082 | FPRR020-5 | FPRR020-5 | AFIAS-6/VB Analyzer is a flurorescence-scanning for in vitro diagnostic use at c AFIAS-6/VB Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in venous whole blood samples.. | AFIAS-6/VB Analyzer | BODITECH MED INC. |
| 19 | 08806133010075 | FPRR020-4 | FPRR020-4 | AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at c AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in serum or plasma samples. | AFIAS-6/SP Analyzer | BODITECH MED INC. |
| 20 | 08806133005279 | AFIAS TSH-VB | SMFP-58 | AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunof AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid indiciduals. | AFIAS TSH-VB | BODITECH MED INC. |
| 21 | 08806133005262 | AFIAS TSH-SP | SMFP-57 | AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunof AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in serum, sodium-heparinized plasma, or EDTA Plasma samples. | AFIAS TSH-SP | BODITECH MED INC. |
| 22 | 08800066300005 | MBD-SC4C-S | ASFA Scanner : Fluorescence scanner for cell analysis used for general cell-base ASFA Scanner : Fluorescence scanner for cell analysis used for general cell-based biochemical analysis. | ASFA SCANNER | MBD CO., LTD. | |
| 23 | 06970136030216 | AFS-1000 | A fluorometer for clinical use is a device intended to measure by fluorescence c A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes | NA | GUANGZHOU LABSIM BIOTECH CO., LTD | |
| 24 | 06970136030100 | AFS2000A | A fluorometer for clinical use is a device intended to measure by fluorescence c A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes | NA | GUANGZHOU LABSIM BIOTECH CO., LTD | |
| 25 | 06438147335022 | 1235-5220 | 1235-5220 | The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel. | AutoDELFIA Automatic Immunoassay System | WALLAC OY |
| 26 | 06438147335008 | 1235-5110 | 1235-5110 | The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel. | AutoDELFIA Automatic Immunoassay System | WALLAC OY |
| 27 | 06438147334780 | 1297-0110 | 1297-0110 | Used with 1235-5220 AutoDELFIA® System (SP and PP). | AutoDELFIA Sample processor | WALLAC OY |
| 28 | 06438147334766 | 1235-0110 | 1235-0110 | Used with 1235-5110 AutoDELFIA® Plate Processor System or 1235-5220 AutoDELFIA® Used with 1235-5110 AutoDELFIA® Plate Processor System or 1235-5220 AutoDELFIA® System (SP and PP). | AutoDELFIA Plate processor | WALLAC OY |
| 29 | 06438147333219 | 1420-0230 | 1420-0230 | The VICTOR EnLite instrument is intended for the quantitative determination of T The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on a filter paper as an aid in screening newborns for severe combined immunodeficiency (SCID) using the polymerase chain reaction (PCR) based EnLite Neonatal TREC kit. | VICTOR EnLite | WALLAC OY |
| 30 | 06438147333202 | 1420-0220 | 1420-0220 | The VICTOR EnLite instrument is intended for the quantitative determination of T The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on a filter paper as an aid in screening newborns for severe combined immunodeficiency (SCID) using the polymerase chain reaction (PCR) based EnLite Neonatal TREC kit. | VICTOR EnLite | WALLAC OY |
| 31 | 06438147311040 | 2021-0010 | 2021-0010 | The GSP® instrument is a fully automated, high throughput batch analyzer for tim The GSP® instrument is a fully automated, high throughput batch analyzer for time-resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only. | Genetic Screening Processor | WALLAC OY |
| 32 | 06438147121373 | 1420-021 | 1420-021 | VICTOR2 D will primarly be used for measuring test kits supplied by Wallac espec VICTOR2 D will primarly be used for measuring test kits supplied by Wallac especially for neonatal tests. Secondly VICTOR2 D can also be used for other measurements of TRF and prompt fluorescence. The user is a laboratory running screening on newborns or a general clinical chemistry lab running different hormones on blood samples. | VICTOR2 D | WALLAC OY |
| 33 | 06438147116157 | 1297-014 | 1297-014 | Used with 1235-514 Fully Automatic DELFIA® System | AutoDELFIA Sample Processor | WALLAC OY |
| 34 | 06438147116133 | 1235-001 | 1235-001 | Used with 1235-501 AutoDELFIA® Plate Processor System or 1235-514 Fully Automati Used with 1235-501 AutoDELFIA® Plate Processor System or 1235-514 Fully Automatic DELFIA® System | AutoDELFIA Plate Processor | WALLAC OY |
| 35 | 06438147116126 | 1420-020 | 1420-020 | VICTOR2 D will primarly be used for measuring test kits supplied by Wallac espec VICTOR2 D will primarly be used for measuring test kits supplied by Wallac especially for neonatal tests. Secondly VICTOR2 D can also be used for other measurements of TRF and prompt fluorescence. The user is a laboratory running screening on newborns or a general clinical chemistry lab running different hormones on blood samples. | VICTOR2 D | WALLAC OY |
| 36 | 04897078440106 | THETIS220 | 10103 | Thetis Fluorescent Immunoassay System (THETIS220) is a rapid and portable rapid Thetis Fluorescent Immunoassay System (THETIS220) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. This device is a fluorescent immunoassay system intended to be used with Test Kits manufactured by Sanwa BioTech. This device is for professional use in a near-patient setting or laboratory use. | Thetis Fluorescent Immunoassay System | SANWA BIOTECH LIMITED |
| 37 | 04897078440052 | ARIEL220 | 10102 | Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable r Ariel Fluorescent Immunoassay System (model: ARIEL220) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. This device is a fluorescent immunoassay system intended to be used with Test Kits manufactured by Sanwa BioTech. This device is for professional use in a near-patient setting or laboratory use. | Ariel Fluorescent Immunoassay System | SANWA BIOTECH LIMITED |
| 38 | 04897078440045 | DX320 | 10101 | ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platfo ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. ALiA FIA Analyser is intended to be used alongside with IVD and other test kits developed by Sanwa BioTech. ALiA is to be used for the detection of fluorescent signals in immunoassays for the identification of biomarkers in near-patient testing or for laboratory use. | ALiA FIA Analyser | SANWA BIOTECH LIMITED |
| 39 | 04560189284623 | AIA-2000 LA | N/A | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 LA | TOSOH CORPORATION | |
| 40 | 04560189284616 | AIA-2000 ST | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-2000 ST | TOSOH CORPORATION | ||
| 41 | 04560189284012 | N/A | 19tray Sorter | TOSOH CORPORATION | ||
| 42 | 04560189284005 | N/A | 9tray Sorter | TOSOH CORPORATION | ||
| 43 | 04560189283992 | AIA-900 | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | TOSOH CORPORATION | ||
| 44 | 04560189282896 | AIA-360 | AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 | TOSOH CORPORATION | ||
| 45 | 00819704020203 | 3154 | 3154 | SEEKER™ Instrument & AccessoriesThe SEEKER™ Instrument is a quantitative in vitr SEEKER™ Instrument & AccessoriesThe SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes. | SEEKER™ | BAEBIES, INC. |
| 46 | 00819704020197 | 2188 | 2188 | The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes. | SEEKER™ | BAEBIES, INC. |