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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 00628063401154 SK350-CAL SK350-CAL JIT Calibrator, secondary 2 HbA1c Calibrators
9 00628063401116 SK252-20 SK252-20 DCF ALBUMIN, ANTIGEN, ANTISERUM, CONTROL 2 Microalbumin
10 00628063400690 80-4604-00 80-4604-00 LBR LDL & VLDL PRECIPITATION, HDL 1 N-geneous LDL Cholesterol Reagent (R1)
11 00628063400652 327-30 327-30 CFJ NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE 2 LACTATE DEHRYDROGENASE-SL Assay
12 00628063400225 SK284-20 SK284-20 CIG DIAZO COLORIMETRY, BILIRUBIN 2 Total Bilirubin
13 00628063400164 247-30 247-30 CIG DIAZO COLORIMETRY, BILIRUBIN 2 DIRECT BILIRUBIN-SL Assay
14 00628063400089 328-30 328-30 CJE NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES 2 ALKALINE PHOSPHATASE-SL
15 00742860100161 175 175 LYR Helicobacter pylori OSOM H Pylori 25 Test Kit
16 00628063401086 SK273-40 SK273-40 DIC ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD 2 Ethanol Assay
17 00742860001475 147 147 GTY ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. OSOM Ultra Strep A 25 Test Kit
18 00628063400867 511-40 511-40 DKJ COLORIMETRY, SALICYLATE 2 SALICYLATE-SL Assay
19 00628063400850 SK117-20 SK117-20 CEO Phosphomolybdate (colorimetric), inorganic phosphorus 1 PHOSPHORUS
20 00628063400799 175-12 175-12 JGJ PHOTOMETRIC METHOD, MAGNESIUM MAGNESIUM Reagent
21 00742860001024 102W 102W JHI Visual, pregnancy hCG, prescription use OSOM hCG Card 25 Test Kit
22 00742860100093 138 138 JJX Single (specified) analyte controls (assayed and unassayed) 1 HCG SERUM CONTROL KIT
23 00628063401178 SK350-BLK SK350-BLK JIT Calibrator, secondary HbA1c Blank Solution
24 00628063401161 SK350-QC SK350-QC JJX Single (specified) analyte controls (assayed and unassayed) 1 HbA1c Controls
25 00628063401147 SK350-60 SK350-60 PDJ,LCP Hemoglobin A1c test system,ASSAY, GLYCOSYLATED HEMOGLOBIN 2 HbA1c Assay
26 00628063400454 SM-052 SM-052 JJY Multi-analyte controls, all kinds (assayed) DC-TROL Level 1
27 00628063400430 250-20 250-20 DCK C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL 2 Wide Range CRP Assay
28 00628063400140 319-30 319-30 CIT Nadh oxidation/nad reduction, ast/sgot 2 AST-SL
29 00628063400072 SK200-10 SK200-10 CIX BROMCRESOL GREEN DYE-BINDING, ALBUMIN ALBUMIN
30 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
31 00742860100147 191 191 GNX ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C OSOM Influenza Control Kit
32 00742860001499 149 149 GTY ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. OSOM Ultra Strep A 50 Test Kit
33 00742860100178 176 176 JJX Single (specified) analyte controls (assayed and unassayed) 1 OSOM H. Pylori Control Kit
34 00742860001451 145 145 KTN SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS OSOM Mono 25 Test Kit
35 00628063400935 153-90 153-90 JMO Ferrozine (colorimetric) iron binding capacity 1 UIBC-SL
36 00628063400928 153-10 153-10 JMO Ferrozine (colorimetric) iron binding capacity 1 UIBC-SL
37 00742860100048 755725 755725 KTN SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS MONO, MERIDIAN IMMUNO 25 Test Kit
38 00628063400980 SK283-10 SK283-10 CDQ UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN UREA
39 00628063400959 153-50 153-50 JMO Ferrozine (colorimetric) iron binding capacity 1 UIBC-SL
40 00628063400942 153-30 153-30 JMO Ferrozine (colorimetric) iron binding capacity 1 UIBC-SL
41 00628063400904 236-99 236-99 CDT LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES 1 TRIGLYCERIDE-SL
42 00628063400898 236-60 236-60 CDT LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES TRIGLYCERIDE-SL
43 00628063400836 SE-252 SE-252 JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 MICROALBUMIN Calibrators
44 00628063400744 80-5666-02 80-5666-02 JIS CALIBRATOR, PRIMARY N-geneous LDL-ST Cholesterol Calibrator
45 00628063400492 273-30 273-30 DIC ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD 2 ETHANOL L3K Assasy
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 16438153817793 NONE 981779 For in vitro diagnostic use in the quantitative determination of the glucose con Glucose (HK) THERMO FISHER SCIENTIFIC OY
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19 03610230007020 1300023849 R1= 4x57mLR2= 3x26mL Yumizen C1200 Glucose HK HORIBA ABX SAS
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21 03610230005217 1220001668 ABX PENTRA GLUCOSE PAP CP HORIBA ABX SAS
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23 00857969006129 SA1014 SA1014 Glucose Reagent ACE ALFA WASSERMANN, INC.
24 00852169008140 GLU1140 GLU1140 In Vitro Diagnostics testing kit R1:4X60mL ClearChem Diagnostics Inc. Glucose CLEARCHEM DIAGNOSTICS INC.
25 00851445007235 GEN-GLU4 GEN-GLU4 10/17/2022 GENCHEM™ Glucose Reagent GENCHEM INC
26 00845275002423 TR15421 Thermo Scientific Infinity™ FISHER DIAGNOSTICS
27 00842768015663 10445162 K1039 Glucose Flex® reagent cartridge, 480 tests Dimension Vista® Flex® reagent cartridge GLU SIEMENS HEALTHCARE DIAGNOSTICS INC.
28 00842768005541 10444971 DF40 Glucose Flex® reagent cartridge, 1440 tests Dimension® Flex® reagent cartridge GLUC SIEMENS HEALTHCARE DIAGNOSTICS INC.
29 00817302023169 CLC480i CLC480i CLC480 Chemistry Analyzer W/ISE CLC480 Chemistry Analyzer W/ISE CAROLINA LIQUID CHEMISTRIES CORPORATION
30 00817302023152 CLC720 CLC720 CLC720 Chemistry Analyzer w/ISE CLC720 Chemistry Analyzer w/ISE CAROLINA LIQUID CHEMISTRIES CORPORATION
31 00817302022995 DT208 DT208 GLU (Glucose) 4 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208 CAROLINA LIQUID CHEMISTRIES CORPORATION
32 00817302020656 88807 88807 GLU3 (Glucose) - CX3 Reagent 1 x 500 mL CAROLINA LIQUID CHEMISTRIES CORP.® GLUCOSE REAGENT 88807 CAROLINA LIQUID CHEMISTRIES CORPORATION
33 00817302020649 CC208 CC208 GLU (Glucose) 2 x 300 tests CAROLINA LIQUID CHEMISTRIES CORP.® GLU GLUCOSE REAGENT CC208 CAROLINA LIQUID CHEMISTRIES CORPORATION
34 00817302020632 AU-208 AU-208 GLU (Glucose) 3 x 250 tests CAROLINA LIQUID CHEMISTRIES CORP.® GLU RGT. KIT AU-208 CAROLINA LIQUID CHEMISTRIES CORPORATION
35 00817302020625 BL208 BL208 GLU (Glucose) 3 x 110 tests CAROLINA LIQUID CHEMISTRIES CORP.® GLU RGT. KIT BL-208 CAROLINA LIQUID CHEMISTRIES CORPORATION
36 00817302020618 ST208 ST208 GLU (Glucose) 4 x 200 tests CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 GLU RGT KIT Product No. ST208 CAROLINA LIQUID CHEMISTRIES CORPORATION
37 00817238011148 R85411 Glucose UV REAGENT Glucose UV REAGENT CLINIQA CORPORATION
38 00812137011985 500mL 501-411 For the in vitro quantitative measurement of glucose in serum. The measurement Glucose Reagent CLINICAL DIAGNOSTIC SOLUTIONS, INC.
39 00811727016157 16-G7517-528 16-G7517-528 Pointe Glucose Reagent packaged for use on the Mindray BA800. 8 x 66ml. For t Pointe Glucose Reagent POINTE SCIENTIFIC, INC.
40 00811727015846 14-G7517-480 14-G7517-480 Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. Fo Pointe Glucose Hexokinase for BS480 POINTE SCIENTIFIC, INC.
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43 00811727011176 G7517-500 G7517-500 Reagent for the in vitro quantitative measurement of glucose in serum. 1 x 500ml Pointe Scientific, Inc. POINTE SCIENTIFIC, INC.
44 00657498001615 S1060-600 S1060-600 For the Quantitative Determination of Glucose in Serum, Plasma, CSF or Urine. Sirrus® Glucose Liqui-UV® STANBIO LABORATORY, L.P.
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46 00630414596488 11097592 11097592 Glucose Hexokinase ( GluH_3) Atellica CH - RGT 6240T Atellica CH GluH_3 SIEMENS HEALTHCARE DIAGNOSTICS INC.
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