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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
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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
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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
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11 06970429841444 14P Drug Test 14P Drug Test co-innovation CO-INNOVATION BIOTECH CO., LTD
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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.