| 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 | 00628063400492 | 273-30 | 273-30 | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | 2 | ETHANOL L3K Assasy | |
| 47 | 00742860100406 | 1034 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | OSOM ULTRA PLUS FLU A&B Control Kit | ||
| 48 | 00742860100345 | 1031 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | Acucy Calibration Device | ||
| 49 | 00628063400805 | 450-50 | 450-50 | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | TOTAL PROTEIN (MICRO) Assay | |
| 50 | 00628063400706 | 80-4607-00 | 80-4607-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R2) |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04015630924837 | 5166888190 | 5166888190 | Alkaline Phosphatase acc to IFCC Gen2 | ROCHE DIAGNOSTICS GMBH | |
| 2 | 04015630921997 | 4657373190 | 4657373190 | Alkaline phosphatase acc to IFCC Gen2 | ROCHE DIAGNOSTICS GMBH | |
| 3 | 04015630919512 | 3333752190 | 3333752190 | Alkaline Phosphatase acc to IFCC Gen2 | ROCHE DIAGNOSTICS GMBH | |
| 4 | 04015630919505 | 3333701190 | 3333701190 | Alkaline Phosphatase acc to IFCC Gen2 | ROCHE DIAGNOSTICS GMBH | |
| 5 | 04015630916443 | 12173174122 | 12173174122 | Alkaline phosphatase liquid acc to IFCC | ROCHE DIAGNOSTICS GMBH | |
| 6 | 04015630916436 | 12173158122 | 12173158122 | Alkaline phosphatase liquid acc to IFCC | ROCHE DIAGNOSTICS GMBH | |
| 7 | 04015630916429 | 12173107122 | 12173107122 | Alkaline phosphatase liquid acc to IFCC | ROCHE DIAGNOSTICS GMBH | |
| 8 | 03610230006832 | 1300023830 | Yumizen C1200 ALP | HORIBA ABX SAS | ||
| 9 | 03610230004890 | 1220001626 | ABX PENTRA ALP CP | HORIBA ABX SAS | ||
| 10 | 00857969006303 | SA2002 | SA2002 | Alkaline Phosphatase Reagent | ACE | ALFA WASSERMANN, INC. |
| 11 | 00857969006297 | RX2002 | RX2002 | Alkaline Phosphatase Reagent | ACE | ALFA WASSERMANN, INC. |
| 12 | 00852169008027 | ALP1010 | ALP1010 | In Vitro Diagnostics testing kit R1:3X48mL, R2:3X12mL | ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) | CLEARCHEM DIAGNOSTICS INC. |
| 13 | 00851445007037 | GEN-ALP R2 | GEN-ALP R2 | 10/17/2022 | GENCHEM™ Alkaline Phosphatase | GENCHEM INC |
| 14 | 00851445007020 | GEN-ALP R1 | GEN-ALP R1 | 10/17/2022 | GENCHEM™ Alkaline Phosphatase | GENCHEM INC |
| 15 | 00845275000412 | TR11320 | Thermo Scientific | FISHER DIAGNOSTICS | ||
| 16 | 00817439020147 | ALP600 | ALP600 | For the quantitative determination of alkaline phosphatase in human serum using For the quantitative determination of alkaline phosphatase in human serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only.100 ml kit | MedTest DX Alkaline Phosphatase | MEDTEST DX, INC. |
| 17 | 00817439020130 | ALP505 | ALP505 | For the quantitative in vitro determination of Alkaline Phosphatase (ALP) in ser For the quantitative in vitro determination of Alkaline Phosphatase (ALP) in serum and plasma. 6 x 51 ml, 6 x 14 ml | ALP Reagent | MEDTEST DX, INC. |
| 18 | 00817439020123 | ALP480 | ALP480 | For the quantitative determination of Albumin in serum using the Mindray BS-480 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device.3 x 60 ml, 3 x 15 ml | Alkaline Phos/ BS480 | MEDTEST DX, INC. |
| 19 | 00817302023015 | DT206 | DT206 | ALP (Alkaline Phosphatase) 4 x 275 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALP REAGENT PRODUCT NO. DT206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 20 | 00817302020267 | CC206 | CC206 | ALP (Alkaline Phosphatase) 2 x 200 tests. | CAROLINA LIQUID CHEMISTRIES CORP.® ALP ALKALINE PHOSPHATASE REAGENT CC206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 21 | 00817302020250 | BL206 | BL206 | ALP (Alkaline Phosphatase) 3 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT BL-206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 22 | 00817302020243 | AU-206 | AU-206 | ALP (Alkaline Phosphatase) 3 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT AU-206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 23 | 00817302020236 | ST206 | ST206 | ALP (Alkaline Phosphatase) 4 x 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALP RGT KIT Product No. ST206 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 24 | 00817274022443 | ALP2-BUL-R2 | ALP2-BUL-R2 | Alkaline Phosphatase Bulk Liquid R1 2.5 L | JAS Diagnostics | DREW SCIENTIFIC, INC. |
| 25 | 00817274022436 | ALP2-BUL-R1 | ALP2-BUL-R1 | Alkaline Phosphatase Bulk Liquid R1 10 L | JAS Diagnostics | DREW SCIENTIFIC, INC. |
| 26 | 00817274020739 | ALT2-P1L | ALT 1L PALS | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 27 | 00817274020722 | ALP2-30R2U | ALP R2 (1x 30mL) UV | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 28 | 00817274020715 | ALP2-120R1U | ALP R1 (1x 120mL) Unlabeled Vial | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 29 | 00817274020708 | XL-ALP2-40 | ALP LIQUID REAGENT (5 x 40 mL) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 30 | 00817274020692 | ALP2-1L | ALP LIQUID (1x 1L R1, 2x 125mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 31 | 00817274020685 | ALP2-120 | ALP LIQUID (1x 120mL R1, 1x 30mL R2) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
| 32 | 00812137011855 | R1 x 500 mL, R2 x 125 mL | 501-398 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Serum alkaline phosphatase estimations are of interest in the diagnosis of two groups of conditions; hepatobiliary disease and bone disease associated with increased osteoblastic activity. | Alkaline Phosphatase Reagent Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| 33 | 00811727016010 | 16-A7516-252 | 16-A7516-252 | Pointe Alkaline Phosphatase Reagent packaged for use on the Mindray BA800. 4 x 5 Pointe Alkaline Phosphatase Reagent packaged for use on the Mindray BA800. 4 x 50ml R1, 4 x 13ml R2. For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | Pointe Alkaline Phosphatase Reagent | POINTE SCIENTIFIC, INC. |
| 34 | 00811727015709 | 14-A7516-225 | 14-A7516-225 | Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the quantitative determination of alkaline phosphatase in human serum on the BS480 Analyzer.. For in vitro diagnostic use only. | Pointe Alkaline Phosphatase on the BS480 | POINTE SCIENTIFIC, INC. |
| 35 | 00811727014597 | HA716-2400 | HA716-2400 | Alkaline Phosphatase Reagent, for the quantitative determination of alkaline pho Alkaline Phosphatase Reagent, for the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Size: 1 x 2 L, 1 x 400 mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 36 | 00811727013743 | 13-A7516-R2-30 | 13-A7516-R2-30 | For the quantitative determination of Alanine Aminotransferase in serum. | Alk Phos R2 (w/ssa#) | POINTE SCIENTIFIC, INC. |
| 37 | 00811727013736 | 13-A7516-R2-125 | 13-A7516-R2-125 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | Alk Phos R2 (w/ssa#) | POINTE SCIENTIFIC, INC. |
| 38 | 00811727013729 | 13-A7516-R1-500 | 13-A7516-R1-500 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | Alk Phos R1 (w/ssa#) | POINTE SCIENTIFIC, INC. |
| 39 | 00811727013712 | 13-A7516-R1-120 | 13-A7516-R1-120 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | Alk Phos R1 (w/ssa#) | POINTE SCIENTIFIC, INC. |
| 40 | 00811727013392 | 12-A7516-100 | 12-A7516-100 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Alkaline Phosphatase | POINTE SCIENTIFIC, INC. |
| 41 | 00811727012876 | HA916-302 | HA916-302 | Alkaline Phosphatase Reagent, for the quantitative determination of alkaline pho Alkaline Phosphatase Reagent, for the quantitative determination of alkaline phosphatase in human serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 5 x 50mL, 4 x 13mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 42 | 00811727012531 | HA916-492 | HA916-492 | Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in human serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 4 x 100ml, 4 x 23ml | Pointe Scientific Inc. | POINTE SCIENTIFIC, INC. |
| 43 | 00811727010155 | A7516-625 | A7516-625 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) | POINTE SCIENTIFIC, INC. |
| 44 | 00811727010148 | A7516-450 | A7516-450 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) | POINTE SCIENTIFIC, INC. |
| 45 | 00811727010131 | A7516-150 | A7516-150 | For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) | POINTE SCIENTIFIC, INC. |
| 46 | 00657498001646 | S2900-600 | S2900-600 | For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum or Plasma. | Sirrus® Alkaline Phosphatase LiquiColor® | STANBIO LABORATORY, L.P. |
| 47 | 00657498000458 | 2900-500 | 2900-500 | For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for Manual and/or Automated Procedures. | Alkaline Phosphatase LiquiColor® | STANBIO LABORATORY, L.P. |
| 48 | 00657498000441 | 2900-430 | 2900-430 | For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum for Manual and/or Automated Procedures. | Alkaline Phosphatase LiquiColor® | STANBIO LABORATORY, L.P. |
| 49 | 00628063401192 | SK328-40 | SK328-40 | Alkaline Phosphatase | SEKISUI DIAGNOSTICS, LLC | |
| 50 | 00628063400096 | SK328-20 | SK328-20 | ALKALINE PHOSPHATASE | SEKISUI DIAGNOSTICS, LLC |