No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10758750007455 | 6901939 | 6901939 | Anti-D BIOCLONE 3x10ml | BIOCLONE | |||
2 | 10758750007448 | 6901935 | 6901935 | Anti-B BIOCLONE 3x10ml | BIOCLONE | |||
3 | 10758750007431 | 6901934 | 6901934 | Anti-A BIOCLONE 3x10ml | BIOCLONE | |||
4 | 10758750004140 | 721380 | 721380 | Anti-Jka (Monoclonal) BioClone | BIOCLONE | |||
5 | 10758750005901 | MTS080212 | MTS080212 | MTS Anti-E (Monoclonal) Card | MTS | |||
6 | 10758750003570 | 716540 | 716540 | C3B C3D BIOCLONE 1X3ML | BIOCLONE | |||
7 | 10758750004157 | 721480 | 721480 | Anti-Jkb (Monoclonal) BioClone | BIOCLONE | |||
8 | 10758750003662 | 717380 | 717380 | ANTI-D BIOCLONE 15X10ML | BIOCLONE | |||
9 | 10758750003624 | 716980 | 716980 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML Green | BIOCLONE | |||
10 | 10758750003600 | 716910 | 716910 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML Green | BIOCLONE | |||
11 | 10758750003563 | 716530 | 716530 | ANTI-C3D BIOCLONE 1X3ML | BIOCLONE | |||
12 | 10758750003471 | 716080 | 716080 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML | BIOCLONE | |||
13 | 10758750003457 | 716000 | 716000 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML | BIOCLONE | |||
14 | 10758750003396 | 715380 | 715380 | ANTI-LEB (LE2) (MURINE MONOCLONAL) BIOCLONE 2.0 | BIOCLONE | |||
15 | 10758750003389 | 715280 | 715280 | ANTI-LEA (LE1) (MURINE MONOCLONAL) BIOCLONE 2.0 | BIOCLONE | |||
16 | 10758750003297 | 714180 | 714180 | ANTI-SMALL E (ANTI-RH5) (MONOCLONAL) BIOCLONE 1X5ML | BIOCLONE | |||
17 | 10758750003266 | 714080 | 714080 | ANTI-SMALL C (ANTI-RH4) (MONOCLONAL) BIOCLONE 1X5ML | BIOCLONE | |||
18 | 10758750003259 | 713180 | 713180 | ANTI-E (ANTI-RH3) (MONOCLONAL) BIOCLONE 1X5ML | BIOCLONE | |||
19 | 10758750003198 | 713080 | 713080 | ANTI-C (ANTI-RH2) (MONOCLONAL) BIOCLONE 1X5ML | BIOCLONE | |||
20 | 10758750003129 | 711520 | 711520 | ANTI-A,B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML | BIOCLONE | |||
21 | 10758750003075 | 711320 | 711320 | ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML | BIOCLONE | |||
22 | 10758750003020 | 711220 | 711220 | ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML | BIOCLONE | |||
23 | 10758750034581 | 6199976 | 6199976 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators | QKO | Reagent, coronavirus serological | VITROS | |
24 | 10758750034567 | 6199975 | 6199975 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
25 | 10758750033591 | 6199950 | 6199950 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator | QKP | Coronavirus antigen detection test system. | VITROS | |
26 | 10758750033584 | 6199949 | 6199949 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack | QKP | Coronavirus antigen detection test system. | VITROS | |
27 | 10758750033577 | 6199944 | 6199944 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer | QKP | Coronavirus antigen detection test system. | VITROS | |
28 | 10758750033560 | 6199943 | 6199943 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Controls | QKP | Coronavirus antigen detection test system. | VITROS | |
29 | 10758750033515 | 6802915B | 6802915B | VITROS 5600 Integrated System-Refurbished - Box B | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
30 | 10758750033201 | 6900440 | 6900440 | VITROS 4600 Chemistry System - Refurbished | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
31 | 10758750032136 | 6844288 | 6844288 | VITROS Chemistry Products ALTV Slides | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | VITROS |
32 | 10758750032105 | 6844508 | 6844508 | VITROS Chemistry Products Calibrator Kit 32 | JIX | Calibrator, multi-analyte mixture | 2 | VITROS |
33 | 10758750031986 | 6844458 | 6844458 | VITROS XT 3400 Chemistry System | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
34 | 10758750031801 | 6844296 | 6844296 | VITROS XT Chemistry Products TBIL-ALKP Slides | CJE,CIG | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES,DIAZO COLORIMETRY, BILIRUBIN | 2 | VITROS |
35 | 10758750031795 | 6844295 | 6844295 | VITROS XT Chemistry Products GLU-Ca Slides | CGA,CJY | GLUCOSE OXIDASE, GLUCOSE,AZO DYE, CALCIUM | 2 | VITROS |
36 | 10758750031788 | 6844294 | 6844294 | VITROS XT Chemistry Products UREA-CREA Slides | CDN,JFY | UREASE, PHOTOMETRIC, UREA NITROGEN,ENZYMATIC METHOD, CREATININE | 2 | VITROS |
37 | 10758750031771 | 6844293 | 6844293 | VITROS XT Chemistry Products ALB-TP Slides | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | 2 | VITROS |
38 | 10758750031764 | 6844292 | 6844292 | VITROS XT Chemistry Products TRIG-CHOL Slides | CDT,CHH | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES,ENZYMATIC ESTERASE--OXID LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES,ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | 1 | VITROS |
39 | 10758750031757 | 6844291 | 6844291 | VITROS XT Chemistry Products ALTV-AST Slides | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | VITROS |
40 | 10758750031610 | 6844461 | 6844461 | VITROS XT 7600 Integrated System | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
41 | 10758750031108 | 6844430 | 6844430 | VITROS Chemistry Products LDHI Slides | CFJ | NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE | 2 | VITROS |
42 | 10758750030736 | 6842906 | 6842906 | VITROS Chemistry Products Calibrator Kit 31 | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
43 | 10758750030729 | 6842905 | 6842905 | VITROS Chemistry Products HbA1c Reagent | PDJ | Hemoglobin A1c test system | 2 | VITROS |
44 | 10758750030163 | 6842957 | 6842957 | VITROS Chemistry Products HCY 2 Performance Verifier I, II, III | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
45 | 10758750030156 | 6842956 | 6842956 | VITROS Chemistry Products HCY 2 Reagent | LPS | URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM | 2 | VITROS |
46 | 10758750012343 | 6802445 | 6802445 | VITROS 4600 Chemistry System | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
47 | 10758750011308 | 6801059B | 6801059B | VITROS ECI IMMUNODIAGNOSTIC SYSTEM - Refurbished - Box B | KHO | FLUOROMETER, FOR CLINICAL USE | 1 | VITROS |
48 | 10758750010233 | 8157596 | 8157596 | VITROS Chemistry Products K+ Slides | CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | 2 | VITROS |
49 | 10758750009862 | 6802413B | 6802413B | VITROS 5600 Integrated System - Box B | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
50 | 10758750009763 | 6801759B | 6801759B | VITROS 250 Chemistry System - Refurbished - Box B | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
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 | 10868401000244 | RC12KC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
6 | 10868401000237 | RC05AC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
7 | 10868401000220 | RC10KC | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
8 | 10868401000213 | RC05ACA | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
9 | 10868401000206 | RC05AF | RealityCHECKTM | WOLFE & ASSOCIATES INC | ||
10 | 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. |
11 | 10867802000259 | MCP11A-001 | mCup® | ESCREEN, INC. | ||
12 | 10867802000242 | MCP10A-001 | mCup® | ESCREEN, INC. | ||
13 | 10867802000235 | MCP9A-001 | mCup® | ESCREEN, INC. | ||
14 | 10867802000228 | MCP7A-001 | mCup® | ESCREEN, INC. | ||
15 | 10866415000335 | STDIP3104 | STDIP3104 | Speedy Tests DOA 10 in 1 Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC | Speedy Tests | SPEEDY SOLUTIONS LLC |
16 | 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 | |
17 | 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 | |
18 | 10863451000428 | 1.0 | Individual 10-panel drug test cassette | Quick Test | QUICKCO, LTD | |
19 | 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. |
20 | 10858945006826 | I-DUD-177-461 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
21 | 10858945006819 | I-DUE-197-261 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
22 | 10858945006628 | I-DCB-1115-011 | AlereTM iCassette® Dx | INSTANT TECHNOLOGIES, INC. | ||
23 | 10858945006611 | I-DOA-364 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
24 | 10858945006604 | IS6B | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
25 | 10858945006598 | IS2MT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
26 | 10858945006529 | IS9 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
27 | 10858945006512 | IS5MB | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
28 | 10858945006505 | IS5M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
29 | 10858945006499 | IS5A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
30 | 10858945006482 | IS4M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
31 | 10858945006475 | IS4A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
32 | 10858945006468 | IS3OCT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
33 | 10858945006451 | IS3MCT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
34 | 10858945006444 | IS2CT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
35 | 10858945006437 | IS10 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
36 | 10858945006383 | IS8 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
37 | 10858945006376 | IS6MAP | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
38 | 10858945006369 | IS5MP | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
39 | 10858945006352 | I-DOA-194-191 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
40 | 10858945006345 | I-DUE-164-161 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
41 | 10858945006338 | I-DUE-197-221 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
42 | 10858945006321 | I-DUE-1107-291 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
43 | 10858945006314 | I-DUE-167-012 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
44 | 10858945006307 | I-DUE-167-342 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
45 | 10858945006291 | I-DUD-187-013 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
46 | 10858945006284 | I-DUE-1107-141 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
47 | 10858945006277 | I-DUD-1107-012 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
48 | 10858945006260 | I-DUD-197-014 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
49 | 10858945006253 | I-DUA-147-012 | iCup® | INSTANT TECHNOLOGIES, INC. | ||
50 | 10858945006246 | I-DOA-1137-011 | iCup® | INSTANT TECHNOLOGIES, INC. |