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 | 07613336157817 | 08445672190 | 08445672190 | Ethanol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
2 | 07613336121221 | 08057630190 | 08057630190 | Ethanol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
3 | 06970429841901 | 12P Drug Test | 12P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
4 | 06970429841802 | 18P Drug Test | 18P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
5 | 06970429841703 | 17P Drug Test | 17P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
6 | 06970429841628 | 16P Drug Test | 16P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
7 | 06970429841611 | 16P CUP | co-innovation | CO-INNOVATION BIOTECH CO., LTD | ||
8 | 06970429841536 | 15P Drug Test | 15P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
9 | 06970429841444 | 14P Drug Test | 14P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
10 | 06970429841284 | 12P drug test cup | co-innovation | CO-INNOVATION BIOTECH CO., LTD | ||
11 | 05055273208085 | DA4015 | DA4015 | The ethanol assay is an in vitro diagnostic test for the quantitative analysis o The ethanol assay is an in vitro diagnostic test for the quantitative analysis of ethanol in human urine and serum. | EtOH | RANDOX LABORATORIES LIMITED |
12 | 04015630918959 | 3183777190 | 3183777190 | Ethanol Gen2 | ROCHE DIAGNOSTICS GMBH | |
13 | 00842768023439 | 10445451 | 9K229 | Emit ® II Plus Ethyl Alcohol Assay labeled with the Beckman Coulter® name | Emit® II Plus Ethyl Alcohol Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
14 | 00842768022050 | 10459408 | DF22 | Ethyl Alcohol Flex® reagent cartridge, 120 tests | Dimension® Flex® reagent cartridge ETOH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
15 | 00842768019913 | 10445109 | K5022 | Ethyl Alcohol Flex® reagent cartridge, 200 tests | Dimension Vista® Flex® reagent cartridge ETOH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
16 | 00817830022825 | 07RD-7124 | 07RD-7124 | Immunoassay: Semi-quantitative alcohol saliva test | MP Saliva Alcohol Test Strip | RAPID DIAGNOSTICS INC |
17 | 00817302021387 | CC421 | CC421 | ETHA (Alcohol) w/ cal - UDR CX/LX/DXC 2 x 150 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
18 | 00817302021370 | AU-421 | AU-421 | ETHA (Alcohol) w/ cal 2 x 625 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
19 | 00817302021363 | ST321 | ST321 | ETHA (Alcohol) w/ cal 2 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
20 | 00817302021356 | ST421 | ST421 | ETHA (Alcohol) w/ cal 3 x 375 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
21 | 00817302021349 | BL421 | BL421 | ETHA (Alcohol) w/ cal 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
22 | 00817302021332 | MR421 | MR421 | ETHA (Alcohol) w/ cal 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
23 | 00816862025385 | W53-S | W53-S | 1-Strip; Alcohol Saliva Test | Wondfo Saliva Alcohol Test | WONDFO USA CO., LTD. |
24 | 00816862023015 | W53-S-100BX | W53-S-100BX | 100-Strips; Alcohol Saliva Test Box 100 Pcs | Wondfo | WONDFO USA CO., LTD. |
25 | 00816862022995 | W53-S-25BX | W53-S-25BX | 25-Strips; Alcohol Saliva Test Box 25 Pcs | Wondfo | WONDFO USA CO., LTD. |
26 | 00816862022339 | W53-S-24BX | 24-Strips; Alcohol Saliva Test Box 24 Pcs | Wondfo | WONDFO USA CO., LTD. | |
27 | 00816862020380 | W53-S | W53-S | 1-Strip; Alcohol Saliva Test | Wondfo Saliva Alcohol Test | WONDFO USA CO., LTD. |
28 | 00811727017406 | 60-EA0440-1L | 60-EA0440-1L | Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Ethyl Alcohol Reagent Set | POINTE SCIENTIFIC, INC. |
29 | 00811727017390 | 60-EA0440-100 | 60-EA0440-100 | Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. | Pointe Ethyl Alcohol Reagent Set | POINTE SCIENTIFIC, INC. |
30 | 00811727010063 | A7504-150 | A7504-150 | For the quantitative determination of ethyl alcohol in serum or whole blood. Fo For the quantitative determination of ethyl alcohol in serum or whole blood. For in vitro diagnostic use only. | POINTE SCIENTIFIC ALCOHOL | POINTE SCIENTIFIC, INC. |
31 | 00811727010056 | A7504-39 | A7504-39 | For the quantitative determination of ethyl alcohol in serum or whole blood. Fo For the quantitative determination of ethyl alcohol in serum or whole blood. For in vitro diagnostic use only. | POINTE SCIENTIFIC ALCOHOL | POINTE SCIENTIFIC, INC. |
32 | 00737051863109 | 56001 | ALCO-SCREEN02 is a qualitative screening test used to detect thepresence of ethy ALCO-SCREEN02 is a qualitative screening test used to detect thepresence of ethyl alcohol in human saliva. The test detects relative bloodalcohol concentrations (BAC) greater than or equal to 0.02%. Results areused for the diagnosis of alcohol intoxication. For in-vitro diagnostic use.The assay is a disposable test for one-time use.510K Cleared - CliaWaived | Alco-Screen02 | CHEMATICS, INC. | |
33 | 00737051654806 | 55001 | ALCO-SCREEN is a semi-quantitative screening test used to estimate theBlood Alco ALCO-SCREEN is a semi-quantitative screening test used to estimate theBlood Alcohol Concentration (BAC) using human saliva. The test stripestimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels.Results are used in the diagnosis of alcohol use or intoxication.For in vitro diagnostic use.510K Cleared - CliaWaived | Alco-Screen | CHEMATICS, INC. | |
34 | 00695684400705 | 40070 | Semi-quantitative test for blood alcohol concentration | AIMSTRIP ALCOHOL SALIVA | GERMAINE LABORATORIES, INC | |
35 | 00682607200054 | C031-021 | Mission Saliva Alcohol Test Strips | Mission Saliva Test Strips | ACON LABORATORIES, INC. | |
36 | 00628063401086 | SK273-40 | SK273-40 | Ethanol Assay | SEKISUI DIAGNOSTICS, LLC | |
37 | 00628063400492 | 273-30 | 273-30 | ETHANOL L3K Assasy | SEKISUI DIAGNOSTICS, LLC | |
38 | 00608337150308 | 60156 | Q.E.D. Saliva Alcohol Test A150 | ORASURE TECHNOLOGIES, INC. | ||
39 | B2984090010 | 40900 | 40900 | Saliva Alcohol Test | AlcoCheck | EXPRESS DIAGNOSTIC INT'L, INC. |
40 | B298409000 | 40900 | 40900 | Saliva Alcohol Test | AlcoCheck | EXPRESS DIAGNOSTICS INT'L, INC. |
41 | B07602210 | 0221 | 0221 | Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent (R2): 375 mL. | Ethyl Alcohol Enzymatic Assay | LIN-ZHI INTERNATIONAL, INC. |
42 | B07602200 | 0220 | 0220 | Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent (R2): 37.5 mL. | Ethyl Alcohol Enzymatic Assay | LIN-ZHI INTERNATIONAL, INC. |
43 | 10763924097224 | DS97AC125 | Saliva Alcohol Test Strip | Accustrip Saliva Alcohol Test | JANT PHARMACAL CORPORATION | |
44 | 10673486000993 | D770-25 | D770-25 | Alcohol Dipstick Test Kit (25 Tests) | TECO DIAGNOSTICS | TECO DIAGNOSTICS |