No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00875197005936 | 07972466190 | 07972466190 | cobas Zika (480 tests) | ||||
2 | 00365702398108 | 5530199160 | 5530199160 | GJS | TEST, TIME, PROTHROMBIN | 2 | CoaguChek XS Pro Kit | |
3 | 00075537180075 | 11379194160 | 11379194160 | KHE | REAGENT, OCCULT BLOOD | 2 | Calibration Strip (Urisys 1100, cobas u 411) | |
4 | 00075537018934 | 11893467160 | 11893467160 | CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | 1 | Chemstrip 5 OB Test Strips | |
5 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | MZF | Test, HIV detection | 2 | Elecsys HIV Duo |
6 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
7 | 07613336179512 | 09205683001 | 09205683001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro transport line | |
8 | 07613336179499 | 09205632001 | 09205632001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro SSU | |
9 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
10 | 07613336171677 | 09007784190 | 09007784190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
11 | 07613336171660 | 09007741190 | 09007741190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
12 | 07613336170212 | 08924180160 | 08924180160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
13 | 07613336170182 | 08924163160 | 08924163160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
14 | 07613336166949 | 08836973190 | 08836973190 | MZF | Test, HIV detection | 2 | Elecsys HIV Duo | |
15 | 07613336164884 | 08764760190 | 08764760190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
16 | 07613336159804 | 04985354160 | 04985354160 | Anti-HBs CC 3 Elecsys | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | Anti-HBs CalCheck |
17 | 07613336158784 | 08463662001 | 08463662001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas c 503 analytical unit | |
18 | 07613336155332 | 08372284001 | 08372284001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
19 | 07613336155318 | 08376824190 | 08376824190 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
20 | 07613336154403 | 03500373190 | 03500373190 | MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Ca Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | free PSA CalCheck | |
21 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
22 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
23 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
24 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
25 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
26 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
27 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
28 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
29 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
30 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
31 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
32 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
33 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
34 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
35 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
36 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
37 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
38 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
39 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
40 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
41 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
42 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
43 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
44 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
45 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
46 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
47 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
48 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
49 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
50 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH |
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 | 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. |
12 | 10867802000266 | MCP5A-001 | mCup® | ESCREEN, INC. | ||
13 | 10867802000259 | MCP11A-001 | mCup® | ESCREEN, INC. | ||
14 | 10867802000242 | MCP10A-001 | mCup® | ESCREEN, INC. | ||
15 | 10867802000235 | MCP9A-001 | mCup® | ESCREEN, INC. | ||
16 | 10867802000228 | MCP7A-001 | mCup® | ESCREEN, INC. | ||
17 | 10867802000211 | MCP5-001 | mCup® | ESCREEN, INC. | ||
18 | 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 |
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 | 10858945006628 | I-DCB-1115-011 | AlereTM iCassette® Dx | INSTANT TECHNOLOGIES, INC. | ||
38 | 10858945006611 | I-DOA-364 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
39 | 10858945006604 | IS6B | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
40 | 10858945006598 | IS2MT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
41 | 10858945006529 | IS9 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
42 | 10858945006512 | IS5MB | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
43 | 10858945006505 | IS5M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
44 | 10858945006499 | IS5A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
45 | 10858945006482 | IS4M | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
46 | 10858945006475 | IS4A | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
47 | 10858945006468 | IS3OCT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
48 | 10858945006451 | IS3MCT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
49 | 10858945006444 | IS2CT | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. | ||
50 | 10858945006437 | IS10 | AlereTM iScreen® | INSTANT TECHNOLOGIES, INC. |