No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M769HIVEXPRESS201 | 20 | The Home Access Health Corporation HIV-1 Standard Test System is intended for us The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing. | MVZ | System,Test,Home,Hiv-1 | 3 | Express HIV-1 Test System | |
2 | M769MAUTEST391 | 39 | URINE(MAU) COLLECTION KIT PCP-No Internet | OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 1 | URINE COLLECTION KIT | |
3 | M769MAUTEST371 | 37 | Urine (MAU) sample collection kit | OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 1 | URINE COLLECTION KIT | |
4 | M769A1CPCP841 | 84 | The Home Access A1c Test kit is an in vitro test for the quantitative measuremen The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemoglobin A1c using capillary blood. Measurements obtained through this test kit can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Contains space for Patient PCP information. | HOME ACCESS A1C TEST | ||||
5 | M769A1C821 | 82 | The Home Access A1c Test kit is an in vitro test for the quantitative measuremen The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemoglobin A1c using capillary blood. Measurements obtained through this test kit can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes. | HOME ACCESS A1C TEST | ||||
6 | M769HIVSTANDARD211 | 21 | The Home Access Health Corporation HIV-1 Standard Test System is intended for us The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing. | MVZ | System,Test,Home,Hiv-1 | 3 | HIV-1 Standard Test System | |
7 | M769CHOLESTEROL811 | 81 | Cholesterol Panel Test Kit for the quantitative determination of total cholester Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood. | CHECK UP AMERICAL CHOLESTEROL PANEL | ||||
8 | M769FITCHEK361 | 36 | Fecal Immunochemical Test to screen for Colorectal Cancer. | FIT-CHEK | ||||
9 | M769FITCHEK351 | 35 | Fecal Immunochemical Test to screen for Colorectal Cancer. | FIT-CHEK | ||||
10 | M769FITCHEK341 | 34 | Fecal Immunochemical Test to screen for Colorectal cancer. | FIT-CHEK | ||||
11 | M769FITCHEK331 | 33 | Fecal Immunochemical Test to screen for Colorectal cancer. | FIT-CHEK | ||||
12 | M769CHOLESTEROL801 | 80 | Cholesterol Panel Test Kit for the quantitative determination of total cholester Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood. | CHECK UP AMERICA CHOLESTEROL PANEL |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04015630939947 | 07026889190 | 07026889190 | Elecsys Anti-HCV II | ROCHE DIAGNOSTICS GMBH | |
2 | 04015630936670 | 06427405160 | 06427405160 | Elecsys AntiHCV II immunoassay | ROCHE DIAGNOSTICS GMBH | |
3 | 04015630936663 | 06368921160 | 06368921160 | Elecsys AntiHCV II immunoassay | ROCHE DIAGNOSTICS GMBH | |
4 | 04015630919277 | 03290379160 | 03290379160 | Elecsys PreciControl Anti-HCV | ROCHE DIAGNOSTICS GMBH | |
5 | 04015630919260 | 03290352160 | 03290352160 | Elecsys Anti-HCV Immunoassay | ROCHE DIAGNOSTICS GMBH | |
6 | 00630414597874 | 10995457 | 10995457 | HCV (aHCV) QC Kit - Atellica IM - CLT 2 x 2 x 7.0 mL | Atellica™ IM aHCV QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00630414597867 | 10995456 | 10995456 | HCV (aHCV) - Atellica IM - RGT - 200T | Atellica™ IM aHCV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00630414473178 | 10309062 | 3439141 | HCV(aHCV) Quality Control Material Kit | ADVIA Centaur® Systems HCV QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414473161 | 10309061 | 3438099 | HCV(aHCV) Assay Kit 200T | ADVIA Centaur® HCV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414301341 | 11207260 | 11207260 | Atellica IM aHCV 200T Kit | Atellica IM aHCV 200T | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00630414278759 | 11203483 | 11203483 | ADVIA Centaur HCV 200T Kit | ADVIA Centaur HCV | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
12 | 00630414278742 | 11203473 | 11203473 | Atellica IM aHCV 200T Kit | Atellica IM aHCV 200T | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
13 | 00608337000542 | 1001-0182 | OraQuick HCV Rapid Antibody Test Kit Controls | ORASURE TECHNOLOGIES, INC. | ||
14 | 00608337000535 | 3001-1521 | OraQuick HCV Rapid Antibody Test | ORASURE TECHNOLOGIES, INC. | ||
15 | 00380740130657 | 08P0521 | 08P0521 | Alinity i Anti-HCV Reagent Kit 200 Tests | Alinity | ABBOTT GMBH |
16 | 00380740130640 | 08P0510 | 08P0510 | Alinity i Anti-HCV Controls | Alinity | ABBOTT GMBH |
17 | 00380740130633 | 08P0501 | 08P0501 | Alinity i Anti-HCV Calibrator | Alinity | ABBOTT GMBH |
18 | 00380740001421 | 1L79-35 | 01L7935 | ARCHITECT Anti-HCV Reagent Kit | ARCHITECT | ABBOTT GMBH |
19 | 00380740001414 | 1L79-25 | 01L7925 | ARCHITECT Anti-HCV Reagent Kit | ARCHITECT | ABBOTT GMBH |
20 | 00380740001407 | 1L79-10 | 01L7910 | Architect Anti-HCV Controls | ARCHITECT | ABBOTT GMBH |
21 | 00380740001391 | 1L79-01 | 01L7901 | Architect Anti-HCV Calibrator | ARCHITECT | ABBOTT GMBH |
22 | M769HCV271 | 27 | The Home Access Health Corporation Hepatitis C Check Test System is intended for The Home Access Health Corporation Hepatitis C Check Test System is intended for use by persons to determine if antibodies to HCV (Hepatitis C) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. | Hepatitis C Check | HOME ACCESS HEALTH CORPORATION | |
23 | 10758750002801 | 6802454 | 6802454 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
24 | 10758750001101 | 6801326 | 6801326 | VITROS Immunodiagnostic Products Anti-HCV Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
25 | 10758750001095 | 6801325 | 6801325 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
26 | 07613336154328 | 3290379160 | 03290379160 | PreciControl Anti-HCV | ROCHE DIAGNOSTICS GMBH | |
27 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | Elecsys Anti-HCV II | ROCHE DIAGNOSTICS GMBH |
28 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | Elecsys Anti-HCV II | ROCHE DIAGNOSTICS GMBH |