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 | 05060169690349 | IS-2400 | MRG | System, Test, Vitamin D | 2 | IDS-iSYS 1,25-Dihydroxy Vitamin D | ||
17 | 05060169690059 | AC-20F1 | CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 2 | Ostase®+ BAP EIA | ||
18 | 05060169690028 | AA-54F2 | MRG | System, Test, Vitamin D | 2 | 1,25 Dihydroxy Vitamin D RIA | ||
19 | 05060169690011 | AA-54F1 | MRG | System, Test, Vitamin D | 2 | 1,25 Dihydroxy Vitamin D RIA | ||
20 | 05060169695818 | IS-2830US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Ostase® BAP Control Set | ||
21 | 05060169691124 | CQ-Seal | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | ImCap Seal | ||
22 | 05060169691094 | IS-10DA | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | IDS-iSYS Diluent A | ||
23 | 05060169690455 | AC-57SF1 | MRG | System, Test, Vitamin D | 2 | 25-Hydroxy Vitamin Ds EIA | ||
24 | 05060169690363 | IS-3300 | CJM | Radioimmunoassay, Aldosterone | 2 | IDS-iSYS Aldosterone | ||
25 | 05060169690295 | IS-3930 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Insulin like Growth Factor-1 (IGF-I) Control Set | ||
26 | 05060169690271 | IS-3230 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Intact PTH Control Set | ||
27 | 05060169690240 | IS-3000 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | IDS-iSYS CTX-I (Crosslaps) | ||
28 | 05060169695979 | IS-ID6530 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS SARS-COV-2 IgG Control Set | ||
29 | 05060169695825 | IS-2835US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Ostase® BAP Calibration Verifiers | ||
30 | 05060169690691 | IS-4600 | CGR | Radioimmunoassay, Cortisol | 2 | IDS Cortisol | ||
31 | 05060169690516 | AC-11F1 | NEO | System, Test, Osteocalcin | 2 | N-MID® Osteocalcin ELISA | ||
32 | 05060169695504 | IS-4620 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS Cortisol Calibrator Set | ||
33 | 05060169691322 | IS-5600 | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | IDS SHBG | ||
34 | 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 | ||
35 | 05060169690301 | IS-4400 | CFL | Radioimmunoassay, Human Growth Hormone | 1 | IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) | ||
36 | 05060169690158 | AC-05F1 | JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | Urine BETA CrossLaps® (CTX-I) ELISA | ||
37 | 05060169695306 | IS-2530 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS 25 VitDS Control Set | ||
38 | 05060169690974 | IS-3735 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers | ||
39 | 05060169690851 | IS-4830 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS-iSYS Direct Renin Control Set | ||
40 | 05060169690820 | IS-4630 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | IDS Cortisol 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 | 04719878121156 | GSH-BGM902 - Level 1 | The WowGoHealth Control Solution should be tested on WowGoHealth meter using Wow The WowGoHealth Control Solution should be tested on WowGoHealth meter using WowGoHealth test strips to make sure the meter and test strips are working properly. | WowGoHealth Control Solution - GSH-BGM902 - Level 1 | GOLDEN SMART HOME TECHNOLOGY CORP. | |
2 | 04719871820308 | GOD21 | Perfect 3 Control Solution-Medium | Perfect 3 | BIOTEST MEDICAL CORPORATION | |
3 | 04719871820292 | GOD11/BLL001RO | Oracle Control Solution - Low(BYGOD11BT) | Oracle | BIOTEST MEDICAL CORPORATION | |
4 | 04719871820285 | GOD31 | Perfect 3 Control Solution-High | Perfect 3 | BIOTEST MEDICAL CORPORATION | |
5 | 04719871820278 | GOD21/BLM001ROA | Oracle Control Solution - Medium(BYGOD21BT) | Oracle | BIOTEST MEDICAL CORPORATION | |
6 | 04719871820261 | 8818 | Perfect 3 Blood Glucose Test Strip1.Part Number:BY8818G0NL42.Packing Materials N Perfect 3 Blood Glucose Test Strip1.Part Number:BY8818G0NL42.Packing Materials No.:BL8818PEA | Perfect 3 | BIOTEST MEDICAL CORPORATION | |
7 | 04719871820254 | GOD31/BLH001ROA | Oracle Control Solution- High(BYGOD31BT) | Oracle | BIOTEST MEDICAL CORPORATION | |
8 | 04719871820247 | 6268 | Perfect 3 Meter Only | Perfect 3 | BIOTEST MEDICAL CORPORATION | |
9 | 04719871820230 | 8818/BL8818ROA | Oracle Blood Glucose Test Strip(BY8818G0NL4) | Oracle | BIOTEST MEDICAL CORPORATION | |
10 | 04719871820223 | 6267 | Perfect 3 Meter Only: | Perfect 3 | BIOTEST MEDICAL CORPORATION | |
11 | 04719871820216 | 6268(BM6B268ROA) | Oracle Blood Glucose Monitoring System | Oracle | BIOTEST MEDICAL CORPORATION | |
12 | 04719871820209 | GOD11(BZL002HA) | Easy Talk Control Solution-Low(Box) | Easy Talk | BIOTEST MEDICAL CORPORATION | |
13 | 04719871820193 | GOD11(BYGOD11BT) | Easy Talk Control Solution-Low(Vial) | Easy Talk | BIOTEST MEDICAL CORPORATION | |
14 | 04719871820186 | GOD31(BYGOD31BT) | Easy Talk Control Solution-High(Vial) | Easy Talk | BIOTEST MEDICAL CORPORATION | |
15 | 04719871820179 | GOD31(BZH002HA) | Easy Talk Control Solution-High(Box) | Easy Talk | BIOTEST MEDICAL CORPORATION | |
16 | 04719871820162 | 8818(BY8818G0NL4) | Easy Talk Blood Glucose Test Strip(25pc/vial) | Easy Talk | BIOTEST MEDICAL CORPORATION | |
17 | 04719871820155 | 8818(BZ8818G0HAA) | Easy Talk Blood Glucose Test Strip(25x2/Box) | Easy Talk | BIOTEST MEDICAL CORPORATION | |
18 | 04719871820148 | 6277(BYG62277HAD) | Easy Talk Blood Glucose Monitoring System(Glucose Meter) | Easy Talk | BIOTEST MEDICAL CORPORATION | |
19 | 04719871820131 | 6277(BZG62277HAA) | Easy Talk Blood Glucose Monitoring System(Meter Only Kit) | Easy Talk | BIOTEST MEDICAL CORPORATION | |
20 | 04719871820124 | GOD11(BZL002HAB) | Easy Plus II Control Solution Kit-Low | Easy Plus II | BIOTEST MEDICAL CORPORATION | |
21 | 04719871820117 | GOD31(BZH002HAB) | Easy Plus II Control Solution Kit-High | Easy Plus II | BIOTEST MEDICAL CORPORATION | |
22 | 04719871820100 | 8818(BZ8818G0HAB) | Easy Plus II Test Strip 25x2 | Easy Plus II | BIOTEST MEDICAL CORPORATION | |
23 | 04719871820094 | GOD31(BZL001HAB) | Easy Plus II Control Solution-Low | Easy Plus II | BIOTEST MEDICAL CORPORATION | |
24 | 04719871820087 | GOD11(BYGOD31BT) | Easy Plus II Control Solution-High | Easy Plus II | BIOTEST MEDICAL CORPORATION | |
25 | 04719871820070 | 8818(BY8818G0NL4) | Easy Plus II Blood Glucose Test Strip | Easy Plus II | BIOTEST MEDICAL CORPORATION | |
26 | 04719871820063 | 6276-S(BYG60276HA) | Easy Plus II Glucose Meter, 6276-S | Easy Plus II | BIOTEST MEDICAL CORPORATION | |
27 | 04719871820056 | 6276-S(BZG60276HA) | Easy Plus II Blood Glucose Monitoring System 6276-S | Easy Plus II | BIOTEST MEDICAL CORPORATION | |
28 | 04719871820049 | 8228 | Lancing Device | B T M | BIOTEST MEDICAL CORPORATION | |
29 | 04719871820032 | 6276-S | Smartest PersonaII Glucose Meter | Smartest PersonaII | BIOTEST MEDICAL CORPORATION | |
30 | 04719871820025 | GOD21 | Smartest PersonaII Control Solution-M | Smartest PersonaII | BIOTEST MEDICAL CORPORATION | |
31 | 04719871820018 | 8819 | Smartest Persona II Glucose Strip-25pcs | Smartest PersonaII | BIOTEST MEDICAL CORPORATION | |
32 | 04719871820001 | 6276-S | Smartest PersonaII Blood Glucose Monitoring System | Smartest PersonaII | BIOTEST MEDICAL CORPORATION | |
33 | 04713648766486 | UAsure control solution | UASure uric acid control solution | APEX BIOTECHNOLOGY CORP. | ||
34 | 04711200721034 | 3L-10-160032 | 3L-10-160032 | GoodLife Blood Glucose ACH foil packed test strip. | GoodLife foil packed test strip | HMD BIOMEDICAL INC. |
35 | 04560189213159 | N//A | AIA-PACK 25-OH Vitamin D CONTROL SET | TOSOH CORPORATION | ||
36 | 04560189212909 | N/A | 0025428 | AIA-PACK BNP CONTROL SET | TOSOH CORPORATION | |
37 | 04560189212800 | N/A | AIA-PACK Homocysteine Control Set | TOSOH CORPORATION | ||
38 | 04560189212299 | N/A | AIA-PACK bHCG Calibration Verification Test Set | TOSOH CORPORATION | ||
39 | 04560189212282 | N/A | AIA-PACK PRL CALIBRATION VERIFICATION TEST SET | TOSOH CORPORATION | ||
40 | 04560189212275 | N/A | AIA-PACK PAP CALIBRATION VERIFICATION TEST SET | TOSOH CORPORATION | ||
41 | 04560189212268 | N/A | AIA-PACK FSH Calibration Verification Test Set | TOSOH CORPORATION | ||
42 | 04560189212237 | N/A | AIA-PACK AFP Calibration Verification Test Set | TOSOH CORPORATION | ||
43 | 04560189211971 | n/a | AIA-PACK PA CALIBRATION VERIFICATION TEST SET | TOSOH CORPORATION | ||
44 | 04560189210875 | N/A | AIA-PACK Intact PTH CONTROL SET | TOSOH CORPORATION | ||
45 | H628A569341 | A56934 | A56934 | The Access Hybritech p2PSA QC are tri-level controls intended for monitoring sys The Access Hybritech p2PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. | Access Hybritech p2PSA QC | BECKMAN COULTER, INC. |
46 | H628372191 | 37219 | 37219 | The Access Hybritech free PSA QC are bi-level controls intended for monitoring s The Access Hybritech free PSA QC are bi-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free Prostate Specific Antigen (free PSA) using the Access Immunoassay Systems. | Access Hybritech free PSA QC | BECKMAN COULTER, INC. |
47 | H628372091 | 37209 | 37209 | The Access Hybritech PSA QC are tri-level controls intended for monitoring syste The Access Hybritech PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of total Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. | Access Hybritech PSA QC | BECKMAN COULTER, INC. |
48 | 04260236851159 | 3S-01-160037 | 3S-01-160037 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | PRECICHEK AutoCode vial packed test strip | HMD BIOMEDICAL INC. |
49 | 04260236851142 | 3L-10-16003B | 3L-10-16003B | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
50 | 04260236851111 | 3L-10-16003H | 3L-10-16003H | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |