| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10816467020157 | Vit. D Immunoassay | 25000068, 25000073 | 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control | MRG | System, Test, Vitamin D | FastPack® IP Vitamin D Kit Complete | |
| 2 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | JHI | Visual, Pregnancy Hcg, Prescription Use | FastPack® IP hCG Kit (30) | |
| 3 | 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) | |
| 4 | 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 |
| 5 | 00816467020075 | TPSA Verifier | 25000017 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - PSA | |
| 6 | 20816467020086 | TSH Immunoassay | 25000042 | 30 Test Ported TSH Immunoassay Kit | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FastPack® IP TSH Kit (30) | |
| 7 | 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 |
| 8 | 20816467020055 | FT4 Immunoassay | 25000043 | 30 Test Ported FT4 Immunoassay Kit | CEC | Radioimmunoassay, Free Thyroxine | FastPack® IP Free T4 Kit (30) | |
| 9 | 00816467020044 | Testo Cal | 25000014 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - Testosterone | |
| 10 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (90) | |
| 11 | 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) | |
| 12 | 10816467020034 | Testo Immunoassay | 25000009 | 50 Test Non-Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® Testo Kit (50) | |
| 13 | 00816467020105 | hCG Cal | 25000035 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – hCG | |
| 14 | 00816467020143 | Vit. D Verifier | 25000064, 25000074 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - Vitamin D | |
| 15 | 10816467020386 | SARS-CoV-2 IgG Immunoassay | 25000085 | 90 Test Kit SARS-CoV-2 IgG Immunoassay | QKO | Reagent, Coronavirus Serological | FastPack SARS-CoV-2 IgG | |
| 16 | 00816467020020 | TPSA Cal | 25000002 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - PSA | |
| 17 | 00816467020006 | IP System | 08000043, 08000043-R, 08000043-X | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System | |
| 18 | 00816467020099 | TSH Cal | 25000024 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – TSH | |
| 19 | 00816467020068 | FT4 Cal | 25000016 | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibrator Kit – Free T4 | |
| 20 | 00816467020334 | IP System | 08000043-C, 08000043-CR | RoHS Compliant FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System |
| 21 | 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) |
| 22 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (30) | |
| 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 | 00054749004973 | 06P17-26 | I-STAT TBI Control L2 | i-STAT | ABBOTT POINT OF CARE INC. | |
| 2 | 00054749004966 | 06P17-25 | I-STAT TBI Control L1 | i-STAT | ABBOTT POINT OF CARE INC. | |
| 3 | 00054749004959 | 06P17-24 | I-STAT TBI Calibration Verification Set | i-STAT | ABBOTT POINT OF CARE INC. | |
| 4 | B800668160 | 66816 | 66816 | NR Trace Elements | Normal Range Trace Elements | UTAK LABORATORIES, INC. |
| 5 | B800668150 | 66815 | 66815 | HR Trace Elements | High Range Trace Elements | UTAK LABORATORIES, INC. |
| 6 | B800445110 | 44511 | 44511 | STABBS Negative | STABBS Negative | UTAK LABORATORIES, INC. |
| 7 | B800445100 | 44510 | 44510 | STABBS Positive | STABBS Positive | UTAK LABORATORIES, INC. |
| 8 | 30014613337126 | 88755 | 88755 | Quidel Triage Total 5 Calibration Verification | Triage | QUIDEL CARDIOVASCULAR INC. |
| 9 | 30014613337119 | 88754 | 88754 | Quidel Triage Total 5 Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |
| 10 | 30014613337102 | 88753 | 88753 | Quidel Triage Total 5 Control 1 | Triage | QUIDEL CARDIOVASCULAR INC. |
| 11 | 30014613337096 | 88734 | 88734 | Quidel Triage Total 3 Control 2 | Triage | QUIDEL CARDIOVASCULAR INC. |
| 12 | 30014613337089 | 88733 | 88733 | Quidel Triage Total 3 Control 1 | Triage | QUIDEL CARDIOVASCULAR INC. |
| 13 | 20844509001694 | 232755 | 232755 | A whole blood glucose and hemoglobin control designed to evaluate the accuracy a A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 3. | HQ-Chex | STRECK, INC. |
| 14 | 20844509001687 | 232754 | 232754 | A whole blood glucose and hemoglobin control designed to evaluate the accuracy a A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 2. | HQ-Chex | STRECK, INC. |
| 15 | 20844509001670 | 232753 | 232753 | A whole blood glucose and hemoglobin control designed to evaluate the accuracy a A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 1. | HQ-Chex | STRECK, INC. |
| 16 | 17350066140579 | 660-20 | AMH Control | FUJIREBIO DIAGNOSTICS AB | ||
| 17 | 17350066140531 | 240-20 | Lung Marker Control | FUJIREBIO DIAGNOSTICS AB | ||
| 18 | 17350066140524 | 360-20 | Mesothelin Control | FUJIREBIO DIAGNOSTICS AB | ||
| 19 | 17350066140043 | 108-20 | Tumor Marker Control | FUJIREBIO DIAGNOSTICS AB | ||
| 20 | 17290018739072 | FG00004 | The Performance Verification Kit contains a set of serum-based quantitative samp The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only. | Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP | MEMED DIAGNOSTICS LTD | |
| 21 | 15099590233877 | 657365 | 657365 | SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum | Synchron | BECKMAN COULTER, INC. |
| 22 | 15099590228743 | 465939 | 465939 | SYNCHRON Systems 125 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
| 23 | 15099590227357 | 450163 | 450163 | Vigil Serology Control Level 2 | Vigil | BECKMAN COULTER, INC. |
| 24 | 15099590227333 | 450164 | 450164 | Vigil Serology Control Level 3 | Vigil | BECKMAN COULTER, INC. |
| 25 | 15099590227326 | 465440 | 465440 | Vigil Serology Control Level C | Vigil | BECKMAN COULTER, INC. |
| 26 | 15099590227258 | 465912 | 465912 | SYNCHRON Systems 75 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
| 27 | 15099590227234 | 465914 | 465914 | SYNCHRON Systems 20 ng/mL THC Urine Control | Synchron | BECKMAN COULTER, INC. |
| 28 | 15099590226916 | 450120 | 450120 | Vigil Protein Control Level 1 | Vigil | BECKMAN COULTER, INC. |
| 29 | 15099590225384 | 465290 | 465290 | Immunochemistry Systems Level 1 Urine Protein Control | IMMAGE | BECKMAN COULTER, INC. |
| 30 | 15099590224158 | 465300 | 465300 | Immunochemistry Systems Level 2 Urine Protein Control | IMMAGE | BECKMAN COULTER, INC. |
| 31 | 15099590223045 | 450125 | 450125 | Vigil Protein Control Level 2 | Vigil | BECKMAN COULTER, INC. |
| 32 | 15099590222925 | 465980 | 465980 | Vigil Lipid Control Level 2 | Vigil | BECKMAN COULTER, INC. |
| 33 | 15099590222918 | 465981 | 465981 | Vigil Lipid Control Level 3 | Vigil | BECKMAN COULTER, INC. |
| 34 | 15099590222901 | 465982 | 465982 | Vigil Lipid Control Level 4 | Vigil | BECKMAN COULTER, INC. |
| 35 | 15099590222611 | 450130 | 450130 | Vigil Protein Control Level 3 | Vigil | BECKMAN COULTER, INC. |
| 36 | 15099590222604 | 450162 | 450162 | Vigil Serology Control Level 1 | Vigil | BECKMAN COULTER, INC. |
| 37 | 15099590222000 | 474988 | 474988 | SYNCHRON Systems OP 300 Low Urine Control | Synchron | BECKMAN COULTER, INC. |
| 38 | 15099590221997 | 474991 | 474991 | SYNCHRON Systems OP 300 High Urine Control | Synchron | BECKMAN COULTER, INC. |
| 39 | 15099590221270 | 469905 | 469905 | Vigil Lipid Control Level 1 | Vigil | BECKMAN COULTER, INC. |
| 40 | 10851290002567 | CVC 223 | CVC 223 | RNA Medical CVC 223 Multi-Level Carton | RNA Medical | RNA MEDICAL DIVISION |
| 41 | 10851290002550 | CVC 123 | CVC 123 | Carton for CVC 123 | RNA Medical | RNA MEDICAL DIVISION |
| 42 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 43 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 44 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 45 | 10758750008322 | 1009406 | 1009406 | VITROS Immunodiagnostic Products RE Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 46 | 10758750006977 | 6801751 | 6801751 | VITROS Chemistry Products %A1c Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 47 | 10758750006960 | 6801750 | 6801750 | VITROS Chemistry Products %A1c Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 48 | 10758750002702 | 6802349 | 6802349 | VITROS Chemistry Products dTIBC Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 49 | 10758750002696 | 6802348 | 6802348 | VITROS Chemistry Products dTIBC Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 50 | 10627966005305 | C5003-2 | C5003-2 | RAMP® Cardiac Controls - Level 2 | RESPONSE BIOMEDICAL CORP |