No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740059941 | 6E66-58 | 06E6658 | ABBOTT PRISM HBcore Wash Kit | ABBOTT PRISM | |||
2 | 00380740059934 | 3L68-58 | 03L6858 | ABBOTT PRISM HIV O Plus Wash Kit | ABBOTT PRISM | |||
3 | 00380740059927 | 7K35-58 | 07K3558 | ABBOTT PRISM Chagas Wash Kit | ABBOTT PRISM | |||
4 | 00380740050375 | 7A03-30 | 07A0330 | ABBOTT PRISM Purge Concentrate | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
5 | 00380740027056 | 7A03-01 | 07A0301 | ABBOTT PRISM Prime/Purge Accessories | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
6 | 00380740027001 | 1A75-01 | 01A7501 | ABBOTT PRISM Activator Diluent | ABBOTT PRISM | |||
7 | 00380740012403 | 7B36-01 | 07B3601 | ABBOTT PRISM SAMPLE CUPS | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
8 | 00380740011604 | 7A03-31 | 07A0331 | ABBOTT PRISM Line Cleaner | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
9 | 00380740008574 | 6A36-34 | 06A3634 | ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
10 | 00380740008420 | 6A36-11 | 06A3611 | ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
11 | 00380740007911 | 5A07-10 | 05A0710 | ABBOTT PRISM Pipette Tips | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
12 | 00380740007904 | 5A07-01 | 05A0701 | ABBOTT PRISM Reaction Trays | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
13 | 00380740168209 | 01P0603 | 01P0603 | Transplant Pretreatment Tubes | MLM,MKW,NRP | ENZYME IMMUNOASSAY, TRACROLIMUS,CYCLOSPORINE,Sirolimus test system | Alinity-Architect | |
14 | 00380740138400 | 3R97-02 | 03R9702 | ABBOTT PRISM Director Version 2.1 | MTQ | Software, blood virus applications | ABBOTT PRISM | |
15 | 00380740138394 | 3R97-01 | 03R9701 | ABBOTT PRISM Director Version 2.0 | MTQ | Software, blood virus applications | ABBOTT PRISM | |
16 | 00380740137922 | 09D2804 | 09D2804 | ICT Module | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity-Architect |
17 | 00380740063016 | 6E50-68 | 06E5068 | ABBOTT PRISM HTLV-I/HTLV-II Assay Kit | ABBOTT PRISM | |||
18 | 00380740062996 | 6D18-68 | 06D1868 | ABBOTT PRISM HCV Assay Kit | ABBOTT PRISM | |||
19 | 00380740062989 | 6D19-68 | 06D1968 | ABBOTT PRISM HBsAg Assay Kit | ABBOTT PRISM | |||
20 | 00380740062972 | 6E51-68 | 06E5168 | ABBOTT PRISM HBsAg Confirmatory Assay Kit | ABBOTT PRISM | |||
21 | 00380740062965 | 6E66-68 | 06E6668 | ABBOTT PRISM HBcore Assay Kit | ABBOTT PRISM | |||
22 | 00380740062958 | 3L68-68 | 03L6868 | ABBOTT PRISM HIV O Plus Assay Kit | ABBOTT PRISM | |||
23 | 00380740062941 | 7K35-68 | 07K3568 | ABBOTT PRISM Chagas Assay Kit | ABBOTT PRISM | |||
24 | 00380740038403 | 3E60-10 | 03E6010 | ABBOTT PRISM Run Control Kit | ABBOTT PRISM | |||
25 | 00380740059972 | 6E50-58 | 06E5058 | ABBOTT PRISM HTLV-I/HTLV-II Wash Kit | ABBOTT PRISM | |||
26 | 00380740059965 | 6D18-58 | 06D1858 | ABBOTT PRISM HCV Wash Kit | ABBOTT PRISM | |||
27 | 00380740059958 | 6D19-58 | 06D1958 | ABBOTT PRISM HBsAg Wash Kit | ABBOTT PRISM | |||
28 | 00380740039219 | 3E60-11 | 03E6011 | ABBOTT PRISM Positive Run Control Kit | ABBOTT PRISM | |||
29 | 00380740038380 | 6L86-10 | 06L8610 | ABBOTT PRISM Chagas Run Control Kit | ABBOTT PRISM | |||
30 | 00380740038373 | 1A75-10 | 01A7510 | ABBOTT PRISM Activator Line Treatment | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
31 | 00380740030445 | 1A75-02 | 01A7502 | ABBOTT PRISM Activator Concentrate | ABBOTT PRISM | |||
32 | 00380740089535 | 8L34-68 | 08L3468 | ABBOTT ESA Chagas Assay Kit | ABBOTT | |||
33 | 00380740011635 | 7A12-60 | 07A1260 | XSYSTEMS TDx/TDx Flx Methotrexate II Reagent Pack | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
34 | 00380740011628 | 7A12-10 | 07A1210 | XSYSTEMS TDx/TDx Flx Methotrexate II Controls | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
35 | 00380740011611 | 7A12-01 | 07A1201 | XSYSTEMS TDx/TDx Flx Methotrexate II Calibrators | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
36 | 00380740136093 | 04R1301 | 04R1301 | Emerald 22 Autoloader Analyzer | GKZ | Counter, differential cell | 2 | CELL-DYN |
37 | 00380740135737 | 99326-02 | 9932602 | CELL-DYN 1800 System DETERGENT | JCB | DETERGENT | 1 | CELL-DYN |
38 | 00380740135720 | 01H78-02 | 01H7802 | CELL-DYN Sapphire System WBC REAGENT - PART B | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
39 | 00380740135713 | 01H77-02 | 01H7702 | CELL-DYN Sapphire System WBC REAGENT - PART A | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
40 | 00380740120788 | 09H62-01 | 09H6201 | CELL-DYN Emerald 22 Diluent | GIF | DILUENT, BLOOD CELL | 1 | CELL-DYN |
41 | 00380740120771 | 09H6101 | 09H6101 | CELL-DYN Emerald 22 Lyse | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
42 | 00380740120764 | 09H60-01 | 09H6001 | CELL-DYN Emerald 22 Easy Cleaner | JCB | DETERGENT | 1 | CELL-DYN |
43 | 00380740119843 | 09H73-01 | 09H7301 | CELL-DYN 22 Plus Calibrator | KRX | CALIBRATOR FOR CELL INDICES | 2 | CELL-DYN |
44 | 00380740119836 | 09H72-02 | 09H7202 | CELL-DYN 22 Plus Control | GLQ | MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 2 | CELL-DYN |
45 | 00380740119829 | 09H72-01 | 09H7201 | CELL-DYN 22 Plus Control | GLQ | MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 2 | CELL-DYN |
46 | 00380740099916 | 08H67-03 | 08H6703 | CELL-DYN Ruby | GKZ | Counter, differential cell | 2 | CELL-DYN |
47 | 00380740072643 | 07H84-02 | 07H8402 | CELL-DYN 1800 System CN-FREE DIFF LYSE | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
48 | 00380740072445 | 99220-02 | 9922002 | CELL-DYN 1800 System DILUENT | GIF | DILUENT, BLOOD CELL | 1 | CELL-DYN |
49 | 00380740071141 | 07H77-01 | 07H7701 | CELL-DYN 1800 | GKZ | Counter, differential cell | 2 | CELL-DYN |
50 | 00380740021085 | 99644-01 | 9964401 | ENZYM CLNR 2X50 ML | JCB | DETERGENT | 1 | CELL-DYN |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10869419000240 | DOA-154-181 | Express ResultsTM | QUEST DIAGNOSTICS | ||
2 | 10869419000233 | UDOA-12CE-0712-01 | Express ResultsTM | QUEST DIAGNOSTICS | ||
3 | 10869419000226 | UDOA-10CE-1307-01 | Express ResultsTM | QUEST DIAGNOSTICS | ||
4 | 10869419000219 | UDOA-10CA-0503-01 | Express ResultsTM | QUEST DIAGNOSTICS | ||
5 | 10869419000202 | UDOA-6CA-0503-01 | Express ResultsTM | QUEST DIAGNOSTICS | ||
6 | 10868401000244 | RC12KC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
7 | 10868401000237 | RC05AC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
8 | 10868401000220 | RC10KC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
9 | 10868401000213 | RC05ACA | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
10 | 10868401000206 | RC05AF | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
11 | 10867802000280 | eCup | 201 | The eScreen eCup® is a patented urine collection device designed to allow for ra The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCup is placed into the eReader device, its test strips are digitally screened for the presence or absence of drugs of abuse. | eScreen eCup | ESCREEN, INC. |
12 | 10867802000273 | DUE-1117X-071-01 | DUE-1117X-071-01 | The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is int The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test device cannot be read visually and must be used with the xReaderTM. The xCupTM qualitatively detects drug classes in human urine at the following cut-off concentrations:Amphetamines at 500 ng/ml; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL.Configurations of the xCupTM may consist of any combination of the listed drug analytes. The xCupTM only provides a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. | xCupTM | ESCREEN, INC. |
13 | 10867802000266 | MCP5A-001 | mCup® | ESCREEN, INC. | ||
14 | 10867802000259 | MCP11A-001 | mCup® | ESCREEN, INC. | ||
15 | 10867802000242 | MCP10A-001 | mCup® | ESCREEN, INC. | ||
16 | 10867802000235 | MCP9A-001 | mCup® | ESCREEN, INC. | ||
17 | 10867802000228 | MCP7A-001 | mCup® | ESCREEN, INC. | ||
18 | 10867802000211 | MCP5-001 | mCup® | ESCREEN, INC. | ||
19 | 10864040000348 | DOA-12C | Qtest 12 (25 pack) - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD Qtest 12 (25 pack) - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50 | QTEST 12 (25 Pack) | MEDIMPEX UNITED, INC | |
20 | 10864040000331 | DOA-11Ca | Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50 | QTEST 11 (25 pack) | MEDIMPEX UNITED, INC | |
21 | 10864040000324 | DOA-7QT | Qtest 7 (25 Pack) - AMP 1000, BZD 300, COC 300, MET 1000, OPI 2000, OXY 100, THC 50 | QTEST 7 (25 Pack) | MEDIMPEX UNITED, INC | |
22 | 10864040000317 | QT-CUP | Qtest 5 (25 pack) - AMP 1000, COC 300, MET 1000, OPI 2000,THC 50 | QTEST 5 (25 Pack) | MEDIMPEX UNITED, INC | |
23 | 10863451000428 | 1.0 | Individual 10-panel drug test cassette | Quick Test | QUICKCO, LTD | |
24 | 10858945006840 | I-DOA-167-1111 | I-DOA-167-1111 | A rapid, one step screening test for the simultaneous, qualitative detection of A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine. | iCup® | INSTANT TECHNOLOGIES, INC. |
25 | 10858945006826 | I-DUD-177-461 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
26 | 10858945006819 | I-DUE-197-261 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
27 | 10858945006802 | KC990 | AlereTM Tox Screen | INSTANT TECHNOLOGIES, INC. | ||
28 | 10858945006796 | KC840A | AlereTM Tox Screen | INSTANT TECHNOLOGIES, INC. | ||
29 | 10858945006789 | I-DOA-1195 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
30 | 10858945006772 | I-DOA-11105 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
31 | 10858945006765 | I-DOA-1185 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
32 | 10858945006758 | I-DOA-3155 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
33 | 10858945006741 | I-DOA-2155 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
34 | 10858945006734 | I-DOA-1165 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
35 | 10858945006727 | I-DOA-1155 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
36 | 10858945006710 | I-DOA-1145 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
37 | 10858945006666 | I-DTH-102 | AlereTM iCassette® | INSTANT TECHNOLOGIES, INC. | ||
38 | 10858945006628 | I-DCB-1115-011 | AlereTM iCassette® Dx | INSTANT TECHNOLOGIES, INC. | ||
39 | 10858945006611 | I-DOA-364 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
40 | 10858945006604 | IS6B | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
41 | 10858945006598 | IS2MT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
42 | 10858945006529 | IS9 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
43 | 10858945006512 | IS5MB | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
44 | 10858945006505 | IS5M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
45 | 10858945006499 | IS5A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
46 | 10858945006482 | IS4M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
47 | 10858945006475 | IS4A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
48 | 10858945006468 | IS3OCT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
49 | 10858945006451 | IS3MCT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
50 | 10858945006444 | IS2CT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. |