No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05060169693906 | IS-IM100 | IDS Immunocleaner | |||||
2 | 05060169690165 | AC-04F1 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | Alpha CrossLaps® (CTX-I) EIA | ||
3 | 05060169695962 | IS-ID6502 | QKO | Reagent, Coronavirus Serological | IDS SARS-COV-2 IgG | |||
4 | 05060169695801 | IS-2800US | CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 2 | IDS-iSYS Ostase® BAP | ||
5 | 05060169691339 | IS-5630 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS SHBG Control Set | ||
6 | 05060169690950 | IS-3235 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Intact PTH Calibration Verifiers | ||
7 | 05060169690424 | IS-2735S | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers | ||
8 | 05060169690417 | IS-2730S | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25-Hydroxy Vitamin DS Control Set | ||
9 | 05060169690400 | IS-2700S | MRG | System, Test, Vitamin D | 2 | IDS-iSYS 25-Hydroxy Vitamin DS | ||
10 | 05060169690288 | IS-3900 | OAM | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | 1 | IDS-iSYS Insulin like Growth Factor-1 (IGF-1) | ||
11 | 05060169693517 | IS-2200 | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | IDS-iSYS Intact PTHN | ||
12 | 05060169690943 | IS-3035 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers | ||
13 | 05060169690929 | IS-2535 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25 VitDS Calibration Verifiers | ||
14 | 05060169690912 | IS-2435 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 1,25-Dihydroxy Vitamin D Calibration Verifiers | ||
15 | 05060169690370 | IS-3330 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Aldosterone Control Set | ||
16 | 05060169690059 | AC-20F1 | CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 2 | Ostase®+ BAP EIA | ||
17 | 05060169690028 | AA-54F2 | MRG | System, Test, Vitamin D | 2 | 1,25 Dihydroxy Vitamin D RIA | ||
18 | 05060169690011 | AA-54F1 | MRG | System, Test, Vitamin D | 2 | 1,25 Dihydroxy Vitamin D RIA | ||
19 | 05060169695818 | IS-2830US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Ostase® BAP Control Set | ||
20 | 05060169691124 | CQ-Seal | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | ImCap Seal | ||
21 | 05060169691094 | IS-10DA | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | IDS-iSYS Diluent A | ||
22 | 05060169690455 | AC-57SF1 | MRG | System, Test, Vitamin D | 2 | 25-Hydroxy Vitamin Ds EIA | ||
23 | 05060169690363 | IS-3300 | CJM | Radioimmunoassay, Aldosterone | 2 | IDS-iSYS Aldosterone | ||
24 | 05060169690295 | IS-3930 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Insulin like Growth Factor-1 (IGF-I) Control Set | ||
25 | 05060169690271 | IS-3230 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Intact PTH Control Set | ||
26 | 05060169690240 | IS-3000 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | IDS-iSYS CTX-I (Crosslaps) | ||
27 | 05060169695979 | IS-ID6530 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS SARS-COV-2 IgG Control Set | ||
28 | 05060169695825 | IS-2835US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Ostase® BAP Calibration Verifiers | ||
29 | 05060169690691 | IS-4600 | CGR | Radioimmunoassay, Cortisol | 2 | IDS Cortisol | ||
30 | 05060169690516 | AC-11F1 | NEO | System, Test, Osteocalcin | 2 | N-MID® Osteocalcin ELISA | ||
31 | 05060169695504 | IS-4620 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS Cortisol Calibrator Set | ||
32 | 05060169691322 | IS-5600 | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | IDS SHBG | ||
33 | 05060169690318 | IS-4430 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set | ||
34 | 05060169690301 | IS-4400 | CFL | Radioimmunoassay, Human Growth Hormone | 1 | IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) | ||
35 | 05060169690158 | AC-05F1 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | Urine BETA CrossLaps® (CTX-I) ELISA | ||
36 | 05060169695306 | IS-2530 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25 VitDS Control Set | ||
37 | 05060169690974 | IS-3735 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers | ||
38 | 05060169690851 | IS-4830 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Direct Renin Control Set | ||
39 | 05060169690820 | IS-4630 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS Cortisol Control Set | ||
40 | 05060169690752 | IS-2530 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25 VitDS Control Set | ||
41 | 05060169690257 | IS-3030 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS CTX-I (Crosslaps) Control Set | ||
42 | 05060169690172 | AC-10F1 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | Urine CartiLaps ® (CTX-II) EIA | ||
43 | 05060169690097 | AC-62F1 | MRG | System, Test, Vitamin D | 2 | 1,25-Dihydroxy Vitamin D EIA | ||
44 | 05060169690004 | AA-35F1 | MRG | System, Test, Vitamin D | 2 | 25-Hydroxy Vitamin D RIA | ||
45 | 05060169695320 | IS-2520N | MRG | System, Test, Vitamin D | 2 | IDS-iSYS 25 VitDS Calibrator Set | ||
46 | 05060169695283 | IS-2500N | MRG | System, Test, Vitamin D | 2 | IDS-iSYS 25 VitDS | ||
47 | 05060169693708 | IS-5635 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS SHBG Calibration Verifiers | ||
48 | 05060169691223 | IS-310400 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | IDS-iSYS Multi Discipline Automated System | ||
49 | 05060169691117 | CQ-FULL | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | ImCap Rack | ||
50 | 05060169691070 | IS-5135 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 17-OH Progesterone Calibration Verifiers |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03610521185987 | 4.3_v5 | 12006557 | BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
2 | 03610521185970 | 4.3_v5 | 12006556 | Manual & CDs, BioPlex 2200 25-OH Vitamin D STND IFU | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
3 | 03610520524503 | SW4.2V3 | 6653765B | Manual & CDs, 25-OH Vitamin D IFU, SW4.2_v3 US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
4 | 03610520507025 | 4.2_v3 | 12000926 | U.S. Only IFU, Manual & CDs, BioPlex 2200 25-OH Vitamin D IFU SW4.2_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
5 | 03610520506349 | SW4.2 V3 | 6653775A | 25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
6 | 00895160002601 | TF8148 | TF8148 | An in vitro diagnostic test for the determination of vitamin D in human serum an An in vitro diagnostic test for the determination of vitamin D in human serum and plasma specimen. | Fluoro-CheckTM Vitamin D | NANO-DITECH CORPORATION |
7 | 00847865011655 | 6653750 | 6653750 | 25-OH Vitamin D Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
8 | 00842768037740 | 10706480 | RF634 | Dimension® EXL™ Total Vitamin D, 200 tests (4x50) | Dimension® EXL™ Total Vitamin D | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00817302020175 | ST500 | ST500 | Vitamin D-direct w/ cal 1 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET | CAROLINA LIQUID CHEMISTRIES CORPORATION |
10 | 00817302020168 | ST501 | ST501 | Vitamin D-direct control 2 x 2 mL (2 lev) | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
11 | 00816870020419 | 7725-300 | 7725-300A | Monobind AccuBind Vitamin D ELISA Kit - 96 Wells | MONOBIND, INC. | |
12 | 00815762021718 | RDKAP1971 | RDKAP1971 | Human Total 25-OH Vitamin D IVD ELISA Kit | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. |
13 | 00630414600345 | 10995721 | 10995721 | Vitamin D total 25 (OH) (VitD) Diluent Atellica IM CONS (2PK) 2 x 5mL | Atellica IM VitD DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
14 | 00630414600338 | 10995720 | 10995720 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 500T | Atellica™ IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
15 | 00630414600321 | 10995719 | 10995719 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 100T | Atellica™ IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
16 | 00630414592503 | 10699201 | 10699201 | ADVIA Centaur® VITAMIN D TOTAL (VITD) ASSAY | ADVIA Centaur® VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
17 | 00630414588773 | 10632114 | 10632114 | Vitamin D Diluent Bottle - CENTAUR - CONS - 1x25mL | ADVIA Centaur® VitD Diluent Bottle | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
18 | 00630414586212 | 10494100 | 10494100 | Vitamin D Diluent (2PK) - CENTAUR - CAL - 2x25mL | ADVIA Centaur® VitD DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
19 | 00630414293837 | 11206265 | 11206265 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT 500T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
20 | 00630414234489 | 11201773 | 11201773 | Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
21 | 00630414234472 | 11201772 | 11201772 | Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
22 | 00380740142759 | 5P02-12 | 05P0212 | ARCHITECT 25-OH Vitamin D Controls | ARCHITECT | ABBOTT IRELAND |
23 | 00380740142742 | 5P02-02 | 05P0202 | ARCHITECT 25-OH Vitamin D Calibrators | ARCHITECT | ABBOTT IRELAND |
24 | 00380740121952 | 08P4532 | 08P4532 | Alinity i 25-OH Vitamin D Reagent Kit 1000 Tests | Alinity | ABBOTT IRELAND |
25 | 00380740121938 | 08P4522 | 08P4522 | Alinity i 25-OH Vitamin D Reagent Kit 200 Tests | Alinity | ABBOTT IRELAND |
26 | 00380740117818 | 5P02-30 | 05P0230 | ARCHITECT 25-OH Vitamin D Reagent Kit (2000T) | ARCHITECT | ABBOTT IRELAND |
27 | 00380740116446 | 5P02-35 | 05P0235 | ARCHITECT 25-OH Vitamin D Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
28 | 00380740116439 | 5P02-25 | 05P0225 | ARCHITECT 25-OH Vitamin D Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
29 | 00380740082147 | 3L52-37 | 03L5237 | ARCHITECT 25-OH Vitamin D Reagent Kit | ARCHITECT | ABBOTT GMBH |
30 | 00380740082130 | 3L52-27 | 03L5227 | ARCHITECT 25-OH Vitamin D Reagent Kit | ARCHITECT | ABBOTT GMBH |
31 | 00380740082123 | 3L52-12 | 03L5212 | ARCHITECT 25-OH Vitamin D Controls | ARCHITECT | ABBOTT GMBH |
32 | 00380740082116 | 3L52-02 | 03L5202 | ARCHITECT 25-OH Vitamin D Calibrators | ARCHITECT | ABBOTT GMBH |
33 | B2423825DHUE010 | 38-25DHU-E01 | 38-25DHU-E01 | The 25OH Vitamin D Total ELISA Test is intended for the quantitative determinati The 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient. | 25OH Vitamin D Total ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
34 | 30014613333951 | Vitamin D EIA | 8046 | MicroVue Vitamin D EIA | MicroVue | QUIDEL CORPORATION |
35 | 15099590226558 | A98856 | A98856 | The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemilumines The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the UniCel DxI Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency. | Access 25(OH) Vitamin D Total | BECKMAN COULTER, INC. |
36 | 15099590225964 | B24838 | B24838 | The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemilumines The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the Access 2 Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency. | Access 25(OH) Vitamin D Total | BECKMAN COULTER, INC. |
37 | 14560189213125 | N/A | ST AIA-PACK 25-OH Vitamin D | TOSOH CORPORATION | ||
38 | 10816467020157 | Vit. D Immunoassay | 25000068, 25000073 | 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control | FastPack® IP Vitamin D Kit Complete | QUALIGEN INC. |
39 | 10758750030217 | 6844056 | 6844056 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
40 | 08809317540337 | FRVD-AP | FRVDAP 020 | It is used for the quantitative measurement of 25-hydroxy vitamin D and related It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma. | FREND | NANOENTEK, INC. |
41 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | Elecsys Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
42 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | Elecsys Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
43 | 07613336129197 | 07464215160 | 07464215160 | Elecsys Vitamin D total II | ROCHE DIAGNOSTICS GMBH | |
44 | 05400569000230 | KAP1971 | 25OH Vitamin D Total ELISA | 25OH Vitamin D Total | DIASOURCE IMMUNOASSAYS S.A. SA | |
45 | 05060169695320 | IS-2520N | IDS-iSYS 25 VitDS Calibrator Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
46 | 05060169695283 | IS-2500N | IDS-iSYS 25 VitDS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
47 | 05060169690622 | IS-2500 | IDS-iSYS 25 VitDS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
48 | 05060169690455 | AC-57SF1 | 25-Hydroxy Vitamin Ds EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
49 | 05060169690400 | IS-2700S | IDS-iSYS 25-Hydroxy Vitamin DS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
50 | 05060169690349 | IS-2400 | IDS-iSYS 1,25-Dihydroxy Vitamin D | IMMUNODIAGNOSTIC SYSTEMS LIMITED |