No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | JHI | Visual, Pregnancy Hcg, Prescription Use | FastPack® IP hCG Kit (30) | |
2 | 10816467020010 | TPSA Immunoassay | 25000001 | 50 Test Non-Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® Total PSA Kit (50) | |
3 | 00816467020372 | Pro System | 08000067, 08000067-R, 08000067-X | RoHS Compliant 7-chamber FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® Pro System |
4 | 00816467020075 | TPSA Verifier | 25000017 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - PSA | |
5 | 20816467020086 | TSH Immunoassay | 25000042 | 30 Test Ported TSH Immunoassay Kit | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FastPack® IP TSH Kit (30) | |
6 | 00816467020167 | PSA Controls | 25000003 | Two levels of controls for the following assays: TPSA, FPSAFPSA is not available Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Control Kit - PSA |
7 | 20816467020055 | FT4 Immunoassay | 25000043 | 30 Test Ported FT4 Immunoassay Kit | CEC | Radioimmunoassay, Free Thyroxine | FastPack® IP Free T4 Kit (30) | |
8 | 00816467020044 | Testo Cal | 25000014 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - Testosterone | |
9 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (90) | |
10 | 20816467020017 | TPSA Immunoassay | 25000040 | 30 Test Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® IP Total PSA Kit (30) | |
11 | 10816467020034 | Testo Immunoassay | 25000009 | 50 Test Non-Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® Testo Kit (50) | |
12 | 00816467020105 | hCG Cal | 25000035 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – hCG | |
13 | 00816467020143 | Vit. D Verifier | 25000064, 25000074 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - Vitamin D | |
14 | 10816467020386 | SARS-CoV-2 IgG Immunoassay | 25000085 | 90 Test Kit SARS-CoV-2 IgG Immunoassay | QKO | Reagent, Coronavirus Serological | FastPack SARS-CoV-2 IgG | |
15 | 00816467020020 | TPSA Cal | 25000002 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - PSA | |
16 | 00816467020006 | IP System | 08000043, 08000043-R, 08000043-X | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System | |
17 | 00816467020099 | TSH Cal | 25000024 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – TSH | |
18 | 00816467020068 | FT4 Cal | 25000016 | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibrator Kit – Free T4 | |
19 | 00816467020334 | IP System | 08000043-C, 08000043-CR | RoHS Compliant FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System |
20 | 00816467020112 | hCG Diluent | 25000036 | Used to dilute the sample if the test result reads outside the assay range. Max Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample. | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | FastPack® IP hCG Diluent Kit (25) |
21 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (30) | |
22 | 00816467020136 | Multi-Analyte Controls | 25000056 | Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | FastPack® Control Kit |
23 | 30816467020014 | TPSA Immunoassay | 25000057 | 90 Test Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® IP Total PSA Kit (90) | |
24 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | JJX,JIT,CDZ | Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP SHBG | |
25 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | JJX,JIT,CDZ | Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP SHBG |
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. |