No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30014613336754 | RPS-ID-20-U | RPS-ID-20-U | InflammaDry | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | InflammaDry |
2 | 30014613336747 | RPS-ID-20 | RPS-ID-20 | InflammaDry | PFQ,JJX | MMP-9 test system,Single (specified) analyte controls (assayed and unassayed) | 1 | InflammaDry |
3 | 30014613336402 | Trichomonas Assay | M304.U | SolanaTrichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
4 | 30014613336396 | Trichomonas Assay | M304.S | Solana Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
5 | 30014613336082 | Group A Strep Assay | M301 | Solana GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Solana |
6 | 30014613335580 | C1-Inhibitor | A037 | MicroVue C1-Inhibitor Plus EIA | DBA | COMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
7 | 30014613335573 | Bp Plus EIA | A027 | Kit, Quidel Bb Plus | JZH | FACTOR B, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
8 | 30014613335566 | CH50 Eq EIA | A018 | MicroVue CH50 Eq EIA | DAE | COMPLEMENT C9, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
9 | 30014613335559 | CIC-C1q Controls | A013 | MicroVue CIC-C1q Ctrls | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
10 | 30014613335542 | CIC-Raji EIA | A002 | MicroVue CIC-Raji EIA | CZY | COMPLEMENT C1S, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
11 | 30014613335535 | CIC-C1q EIA | A001 | MicroVue CIC-C1q EIA | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
12 | 30014613333944 | PTH EIA | 8044 | MicroVue PTH EIA | CEW | RADIOIMMUNOASSAY, PARATHYROID HORMONE | 2 | MicroVue |
13 | 30014613333937 | Calcitonin EIA | 8043 | MicroVue Calcitonin EIA | JKR | RADIOIMMUNOASSAY, CALCITONIN | 2 | MicroVue |
14 | 30014613333920 | BAP EIA | 8012 | MicroVue BAP EIA | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | MicroVue |
15 | 30014613333913 | PYD EIA | 8010 | Kit, McVu PYD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
16 | 30014613333906 | DPD EIA | 8007 | Kit, McVu DPD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
17 | 30014613311140 | Parainfluenza Virus Assay | M114 | Lyra Parainfluenza Assay | OOU | Parainfluenza multiplex nucleic acid assay | 2 | Lyra |
18 | 30014613311133 | Adenovirus Assay | M113 | Lyra Adenovirus Assay | OCC | Respiratory virus panel nucleic acid assay system | 2 | Lyra |
19 | 30014613311126 | Direct Strep Assay | M112 | Lyra Direct Strep Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Lyra |
20 | 30014613311058 | Direct C. difficile Assay | M105 | Lyra Direct CDIFF Assay | OZN,OOI | C.Difficile toxin gene amplification assay,real time Nucleic acid amplification system | 2 | Lyra |
21 | 30014613311027 | Direct HSV 1+2/VZV Assay | M102 | Lyra Direct HSV 1+2/VZV Assay | PGI | Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutane Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutaneous lesion samples | 2 | Lyra |
22 | 30014613202783 | 20278 | 20278 | Solana instrument | NSU | Instrumentation for clinical multiplex test systems | 2 | Solana |
23 | 30014613003458 | 00345 | 00345 | QkVue InLine Strep A Ctrl Set | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
24 | 30014613003434 | 00343 | 00343 | QkVue InLine Strep A 25T | GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
25 | 30014613336686 | RPS-AD | RPS-AD | AdenoPlus | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | AdenoPlus |
26 | 30014613339724 | 20402 | 20402 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
27 | 30014613339687 | 20399 | 20399 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
28 | 30014613339670 | 20398 | 20398 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
29 | 30014613339373 | 20387 | 20387 | QuickVue® SARS Antigen Test | QuickVue | |||
30 | 30014613331469 | 20189 | 20189 | QkVue Flu A+B 20K-T, Bulk | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
31 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
32 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | LYR | Helicobacter pylori | 1 | QuickVue |
33 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | LYR | Helicobacter pylori | 1 | QuickVue |
34 | 30014613312123 | Group A Strep Assay | M212 | AmpliVue GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | AmpliVue |
35 | 30014613312116 | Trichomonas Assay | M211 | AmpliVue Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | AmpliVue |
36 | 30014613312109 | HSV 1+2 Assay | M210 | AmpliVue HSV 1+2 Assay | OQO | Herpes simplex virus nucleic acid amplification assay | 2 | AmpliVue |
37 | 30014613312093 | Bordetella Assay | M209 | AmpliVue Bordetella Assay | OZZ | Bordetella pertussis dna assay system | 2 | AmpliVue |
38 | 30014613312024 | GBS Assay | M202 | AmpliVue GBS Assay | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | AmpliVue |
39 | 30014613312017 | C. difficile Assay | M201 | AmpliVue CDiff Assay | OZN | C.Difficile toxin gene amplification assay | 2 | AmpliVue |
40 | 30014613202226 | 20222 | 20222 | QkVue RSV 10, 25T | GQG | ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
41 | 30014613202059 | iFOB Test | 20205 | QuickVue iFOB Test Dev Kit 100T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
42 | 30014613202042 | iFOB Test | 20204 | QuickVue iFOB Collect Kit 40T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
43 | 30014613202011 | iFOB Test | 20201 | QuickVue iFOB Tray Pack 50T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
44 | 30014613201977 | 20197 | 20197 | QkVue iFOB Control Set | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
45 | 30014613201960 | iFOB Test | 20196 | QuickVue iFOB Collect Kit 10T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
46 | 30014613201946 | iFOB Test | 20194 | QuickVue iFOB 20T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
47 | 30014613201939 | 20193 | 20193 | QkVue RSV 20T | MCE,GQG | RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRA RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
48 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
49 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
50 | 30014613201250 | 20125 | 20125 | QkVue Strep A Dpstk 25T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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. |
2 | 00630414600338 | 10995720 | 10995720 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 500T | Atellica™ IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
3 | 00630414600321 | 10995719 | 10995719 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 100T | Atellica™ IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
4 | 00630414592503 | 10699201 | 10699201 | ADVIA Centaur® VITAMIN D TOTAL (VITD) ASSAY | ADVIA Centaur® VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00630414588773 | 10632114 | 10632114 | Vitamin D Diluent Bottle - CENTAUR - CONS - 1x25mL | ADVIA Centaur® VitD Diluent Bottle | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00630414586212 | 10494100 | 10494100 | Vitamin D Diluent (2PK) - CENTAUR - CAL - 2x25mL | ADVIA Centaur® VitD DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00630414293837 | 11206265 | 11206265 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT 500T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00630414234489 | 11201773 | 11201773 | Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414234472 | 11201772 | 11201772 | Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00380740142759 | 5P02-12 | 05P0212 | ARCHITECT 25-OH Vitamin D Controls | ARCHITECT | ABBOTT IRELAND |
11 | 00380740142742 | 5P02-02 | 05P0202 | ARCHITECT 25-OH Vitamin D Calibrators | ARCHITECT | ABBOTT IRELAND |
12 | 00380740121952 | 08P4532 | 08P4532 | Alinity i 25-OH Vitamin D Reagent Kit 1000 Tests | Alinity | ABBOTT IRELAND |
13 | 00380740121938 | 08P4522 | 08P4522 | Alinity i 25-OH Vitamin D Reagent Kit 200 Tests | Alinity | ABBOTT IRELAND |
14 | 00380740117818 | 5P02-30 | 05P0230 | ARCHITECT 25-OH Vitamin D Reagent Kit (2000T) | ARCHITECT | ABBOTT IRELAND |
15 | 00380740116446 | 5P02-35 | 05P0235 | ARCHITECT 25-OH Vitamin D Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
16 | 00380740116439 | 5P02-25 | 05P0225 | ARCHITECT 25-OH Vitamin D Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
17 | 00380740082147 | 3L52-37 | 03L5237 | ARCHITECT 25-OH Vitamin D Reagent Kit | ARCHITECT | ABBOTT GMBH |
18 | 00380740082130 | 3L52-27 | 03L5227 | ARCHITECT 25-OH Vitamin D Reagent Kit | ARCHITECT | ABBOTT GMBH |
19 | 00380740082123 | 3L52-12 | 03L5212 | ARCHITECT 25-OH Vitamin D Controls | ARCHITECT | ABBOTT GMBH |
20 | 00380740082116 | 3L52-02 | 03L5202 | ARCHITECT 25-OH Vitamin D Calibrators | ARCHITECT | ABBOTT GMBH |
21 | 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. |
22 | 30014613333951 | Vitamin D EIA | 8046 | MicroVue Vitamin D EIA | MicroVue | QUIDEL CORPORATION |
23 | 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. |
24 | 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. |
25 | 14560189213125 | N/A | ST AIA-PACK 25-OH Vitamin D | TOSOH CORPORATION | ||
26 | 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. |
27 | 10758750030217 | 6844056 | 6844056 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
28 | 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. |
29 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | Elecsys Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
30 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | Elecsys Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
31 | 07613336129197 | 07464215160 | 07464215160 | Elecsys Vitamin D total II | ROCHE DIAGNOSTICS GMBH | |
32 | 05400569000230 | KAP1971 | 25OH Vitamin D Total ELISA | 25OH Vitamin D Total | DIASOURCE IMMUNOASSAYS S.A. SA | |
33 | 05060169695320 | IS-2520N | IDS-iSYS 25 VitDS Calibrator Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
34 | 05060169695283 | IS-2500N | IDS-iSYS 25 VitDS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
35 | 05060169690622 | IS-2500 | IDS-iSYS 25 VitDS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
36 | 05060169690455 | AC-57SF1 | 25-Hydroxy Vitamin Ds EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
37 | 05060169690400 | IS-2700S | IDS-iSYS 25-Hydroxy Vitamin DS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
38 | 05060169690349 | IS-2400 | IDS-iSYS 1,25-Dihydroxy Vitamin D | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
39 | 05060169690097 | AC-62F1 | 1,25-Dihydroxy Vitamin D EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
40 | 05060169690028 | AA-54F2 | 1,25 Dihydroxy Vitamin D RIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
41 | 05060169690011 | AA-54F1 | 1,25 Dihydroxy Vitamin D RIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
42 | 05060169690004 | AA-35F1 | 25-Hydroxy Vitamin D RIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
43 | 04987270235089 | 235089 | Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges | FUJIREBIO INC. | ||
44 | 04560189213142 | N/A | ST AIA-PACK 25-OH Vitamin D PRETREATMENT SET | TOSOH CORPORATION | ||
45 | 04049016097129 | EQ 6411-9601 | 25-OH Vitamin D ELISA | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
46 | 04015630940127 | 07028148190 | 07028148190 | Elecsys Vitamin D total II | ROCHE DIAGNOSTICS GMBH | |
47 | 04015630932429 | 6506780160 | 6506780160 | Elecsys Vitamin D Assay | ROCHE DIAGNOSTICS GMBH | |
48 | 03610521185987 | 4.3_v5 | 12006557 | BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
49 | 03610521185970 | 4.3_v5 | 12006556 | Manual & CDs, BioPlex 2200 25-OH Vitamin D STND IFU | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 03610520524503 | SW4.2V3 | 6653765B | Manual & CDs, 25-OH Vitamin D IFU, SW4.2_v3 US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |