No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00628063400393 | 265-30 | 265-30 | JFY | ENZYMATIC METHOD, CREATININE | 2 | ENZYMATIC CREATININE Assay | |
2 | 00628063400362 | 234-99 | 234-99 | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | 1 | CHOLESTEROL-SL | |
3 | 00628063400355 | 234-60 | 234-60 | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | CHOLESTEROL-SL | ||
4 | 00742860100215 | 1005 | 1005 | OSOM Ultra Flu A&B Controls 5 Test | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | OSOM Ultra Flu A&B Controls 5 Test | |
5 | 00628063400676 | 80-4598-00 | 80-4598-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R1) | |
6 | 00628063400669 | 7120 | 7120 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | LDL Direct LS Cholesterol Reagent Kit | |
7 | 00742860001017 | 101 | 101 | JHI | Visual, pregnancy hCG, prescription use | OSOM hCG Urine 50 Test Kit | ||
8 | 00628063400539 | SK235-10 | SK235-10 | CFR | HEXOKINASE, GLUCOSE | GLUCOSE | ||
9 | 00628063401154 | SK350-CAL | SK350-CAL | JIT | Calibrator, secondary | 2 | HbA1c Calibrators | |
10 | 00628063401116 | SK252-20 | SK252-20 | DCF | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Microalbumin | |
11 | 00628063400690 | 80-4604-00 | 80-4604-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R1) | |
12 | 00628063400652 | 327-30 | 327-30 | CFJ | NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE | 2 | LACTATE DEHRYDROGENASE-SL Assay | |
13 | 00628063400225 | SK284-20 | SK284-20 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Total Bilirubin | |
14 | 00628063400164 | 247-30 | 247-30 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | DIRECT BILIRUBIN-SL Assay | |
15 | 00628063400089 | 328-30 | 328-30 | CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | 2 | ALKALINE PHOSPHATASE-SL | |
16 | 00742860100161 | 175 | 175 | LYR | Helicobacter pylori | OSOM H Pylori 25 Test Kit | ||
17 | 00628063401086 | SK273-40 | SK273-40 | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | 2 | Ethanol Assay | |
18 | 00742860001475 | 147 | 147 | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | OSOM Ultra Strep A 25 Test Kit | ||
19 | 00628063400867 | 511-40 | 511-40 | DKJ | COLORIMETRY, SALICYLATE | 2 | SALICYLATE-SL Assay | |
20 | 00628063400850 | SK117-20 | SK117-20 | CEO | Phosphomolybdate (colorimetric), inorganic phosphorus | 1 | PHOSPHORUS | |
21 | 00628063400799 | 175-12 | 175-12 | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | MAGNESIUM Reagent | ||
22 | 00742860001024 | 102W | 102W | JHI | Visual, pregnancy hCG, prescription use | OSOM hCG Card 25 Test Kit | ||
23 | 00742860100093 | 138 | 138 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HCG SERUM CONTROL KIT | |
24 | 00628063401178 | SK350-BLK | SK350-BLK | JIT | Calibrator, secondary | HbA1c Blank Solution | ||
25 | 00628063401161 | SK350-QC | SK350-QC | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HbA1c Controls | |
26 | 00628063401147 | SK350-60 | SK350-60 | PDJ,LCP | Hemoglobin A1c test system,ASSAY, GLYCOSYLATED HEMOGLOBIN | 2 | HbA1c Assay | |
27 | 00628063400454 | SM-052 | SM-052 | JJY | Multi-analyte controls, all kinds (assayed) | DC-TROL Level 1 | ||
28 | 00628063400430 | 250-20 | 250-20 | DCK | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | 2 | Wide Range CRP Assay | |
29 | 00628063400140 | 319-30 | 319-30 | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | AST-SL | |
30 | 00628063400072 | SK200-10 | SK200-10 | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | ALBUMIN | ||
31 | 00742860100222 | 1006 | 1006 | OSOM Ultra Flu A&B 25T Kit | PSZ | Devices detecting influenza A, B, and C virus antigens | OSOM Ultra Flu A&B 25T Kit | |
32 | 00742860100147 | 191 | 191 | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | OSOM Influenza Control Kit | ||
33 | 00742860001499 | 149 | 149 | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | OSOM Ultra Strep A 50 Test Kit | ||
34 | 00742860100178 | 176 | 176 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | OSOM H. Pylori Control Kit | |
35 | 00742860001451 | 145 | 145 | KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | OSOM Mono 25 Test Kit | ||
36 | 00628063400935 | 153-90 | 153-90 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
37 | 00628063400928 | 153-10 | 153-10 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
38 | 00742860100048 | 755725 | 755725 | KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | MONO, MERIDIAN IMMUNO 25 Test Kit | ||
39 | 00628063400980 | SK283-10 | SK283-10 | CDQ | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | UREA | ||
40 | 00628063400959 | 153-50 | 153-50 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
41 | 00628063400942 | 153-30 | 153-30 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
42 | 00628063400904 | 236-99 | 236-99 | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | 1 | TRIGLYCERIDE-SL | |
43 | 00628063400898 | 236-60 | 236-60 | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | TRIGLYCERIDE-SL | ||
44 | 00628063400836 | SE-252 | SE-252 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | MICROALBUMIN Calibrators | |
45 | 00628063400744 | 80-5666-02 | 80-5666-02 | JIS | CALIBRATOR, PRIMARY | N-geneous LDL-ST Cholesterol Calibrator | ||
46 | 00742860100406 | 1034 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | OSOM ULTRA PLUS FLU A&B Control Kit | ||
47 | 00742860100345 | 1031 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | Acucy Calibration Device | ||
48 | 00628063400805 | 450-50 | 450-50 | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | TOTAL PROTEIN (MICRO) Assay | |
49 | 00628063400706 | 80-4607-00 | 80-4607-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R2) | |
50 | 00628063401130 | SK237-40 | SK237-40 | KNK | Acid, uric, uricase (colorimetric) | Uric Acid Assay |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10763924097224 | DS97AC125 | Saliva Alcohol Test Strip | Accustrip Saliva Alcohol Test | JANT PHARMACAL CORPORATION | |
2 | 10673486000993 | D770-25 | D770-25 | Alcohol Dipstick Test Kit (25 Tests) | TECO DIAGNOSTICS | TECO DIAGNOSTICS |
3 | 07613336157817 | 08445672190 | 08445672190 | Ethanol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
4 | 07613336121221 | 08057630190 | 08057630190 | Ethanol Gen.2 | ROCHE DIAGNOSTICS GMBH | |
5 | 06970429841901 | 12P Drug Test | 12P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
6 | 06970429841802 | 18P Drug Test | 18P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
7 | 06970429841703 | 17P Drug Test | 17P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
8 | 06970429841628 | 16P Drug Test | 16P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
9 | 06970429841611 | 16P CUP | co-innovation | CO-INNOVATION BIOTECH CO., LTD | ||
10 | 06970429841536 | 15P Drug Test | 15P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
11 | 06970429841444 | 14P Drug Test | 14P Drug Test | co-innovation | CO-INNOVATION BIOTECH CO., LTD | |
12 | 06970429841284 | 12P drug test cup | co-innovation | CO-INNOVATION BIOTECH CO., LTD | ||
13 | 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 |
14 | 04015630918959 | 3183777190 | 3183777190 | Ethanol Gen2 | ROCHE DIAGNOSTICS GMBH | |
15 | 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. |
16 | 00842768022050 | 10459408 | DF22 | Ethyl Alcohol Flex® reagent cartridge, 120 tests | Dimension® Flex® reagent cartridge ETOH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
17 | 00842768019913 | 10445109 | K5022 | Ethyl Alcohol Flex® reagent cartridge, 200 tests | Dimension Vista® Flex® reagent cartridge ETOH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
18 | 00817830022825 | 07RD-7124 | 07RD-7124 | Immunoassay: Semi-quantitative alcohol saliva test | MP Saliva Alcohol Test Strip | RAPID DIAGNOSTICS INC |
19 | 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 |
20 | 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 |
21 | 00817302021363 | ST321 | ST321 | ETHA (Alcohol) w/ cal 2 x 300 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
22 | 00817302021356 | ST421 | ST421 | ETHA (Alcohol) w/ cal 3 x 375 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
23 | 00817302021349 | BL421 | BL421 | ETHA (Alcohol) w/ cal 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
24 | 00817302021332 | MR421 | MR421 | ETHA (Alcohol) w/ cal 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
25 | 00816862025385 | W53-S | W53-S | 1-Strip; Alcohol Saliva Test | Wondfo Saliva Alcohol Test | WONDFO USA CO., LTD. |
26 | 00816862023015 | W53-S-100BX | W53-S-100BX | 100-Strips; Alcohol Saliva Test Box 100 Pcs | Wondfo | WONDFO USA CO., LTD. |
27 | 00816862022995 | W53-S-25BX | W53-S-25BX | 25-Strips; Alcohol Saliva Test Box 25 Pcs | Wondfo | WONDFO USA CO., LTD. |
28 | 00816862022339 | W53-S-24BX | 24-Strips; Alcohol Saliva Test Box 24 Pcs | Wondfo | WONDFO USA CO., LTD. | |
29 | 00816862020380 | W53-S | W53-S | 1-Strip; Alcohol Saliva Test | Wondfo Saliva Alcohol Test | WONDFO USA CO., LTD. |
30 | 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. |
31 | 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. |
32 | 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. |
33 | 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. |
34 | 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. | |
35 | 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. | |
36 | 00695684400705 | 40070 | Semi-quantitative test for blood alcohol concentration | AIMSTRIP ALCOHOL SALIVA | GERMAINE LABORATORIES, INC | |
37 | 00682607200054 | C031-021 | Mission Saliva Alcohol Test Strips | Mission Saliva Test Strips | ACON LABORATORIES, INC. | |
38 | 00628063401086 | SK273-40 | SK273-40 | Ethanol Assay | SEKISUI DIAGNOSTICS, LLC | |
39 | 00628063400492 | 273-30 | 273-30 | ETHANOL L3K Assasy | SEKISUI DIAGNOSTICS, LLC | |
40 | 00608337150308 | 60156 | Q.E.D. Saliva Alcohol Test A150 | ORASURE TECHNOLOGIES, INC. | ||
41 | B2984090010 | 40900 | 40900 | Saliva Alcohol Test | AlcoCheck | EXPRESS DIAGNOSTIC INT'L, INC. |
42 | B298409000 | 40900 | 40900 | Saliva Alcohol Test | AlcoCheck | EXPRESS DIAGNOSTICS INT'L, INC. |
43 | 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. |
44 | 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. |