| 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 | 10888277191877 | MPH12025HCG | MPH12025HCG | TEST,HCG,PREGNANCY,URINE,CASS, 25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
| 2 | 10885632116308 | MC02SU | Kit Human Chorionic Gonadotropin Pregnancy Test Urine/Serum 25-Test Not Made Wit Kit Human Chorionic Gonadotropin Pregnancy Test Urine/Serum 25-Test Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
| 3 | 10885632116285 | MC001U | Kit Human Chorionic Gonadotropin Pregnancy Test Urine 25-Test Not Made With Natu Kit Human Chorionic Gonadotropin Pregnancy Test Urine 25-Test Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
| 4 | 10884389191880 | MPH22025HCG | MPH22025HCG | TEST,HCG,PREGNANCY,COMBO,CASS,20/10 MIU | Medline | MEDLINE INDUSTRIES, INC. |
| 5 | 10884389191873 | MPH11025HCG | MPH11025HCG | TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
| 6 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | FastPack® IP hCG Kit (30) | QUALIGEN INC. |
| 7 | 10815845020130 | 92210 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 8 | 10815845020123 | 92215 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 9 | 10815845020116 | 92225 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 10 | 10815845020109 | 92217 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 11 | 10815845020093 | 92211 | AlereTM | ALERE SAN DIEGO, INC. | ||
| 12 | 10796918000108 | 02-2493 | HCG Combo Cassette Test | Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 13 | 10796918000092 | 02-2489 | INSTANT-VIEW HCG Combo Cassette Test | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 14 | 10796918000085 | 02-2488 | INSTANT-VIEW HCG Combo Dip-Strip Test | INSTANT-VIEW Pregnancy Combo Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 15 | 10796918000078 | 02-2487-25 | INSTANT-VIEW HCG Urine Dip-Strip Test | INSTANT-VIEW Pregnancy Urine Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 16 | 10796918000061 | 02-2487 | INSTANT-VIEW HCG Urine Dip-Strip Test | INSTANT-VIEW Pregnancy Urine Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 17 | 10796918000054 | 02-2486 | Instant-View HCG Urine Cassette,4mm | INSTANT-VIEW Pregnancy Urine Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 18 | 10796918000047 | 02-2484 | Instant-View HCG Combo Cassette, 4mm | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 19 | 10796918000030 | 02-2483 | INSTANT-VIEW HCG Combo Cassette Test | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 20 | 10796918000023 | 02-2482 | INSTANT-VIEW HCG Urine Cassette Test | Insant-View Pregnancy Urine Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 21 | 10763924864208 | PF864 | Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) | Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) | JANT PHARMACAL CORPORATION | |
| 22 | 10763924853202 | PF853 | Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived) | Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived) | JANT PHARMACAL CORPORATION | |
| 23 | 10763924851109 | PF851 | Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived) | Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived) | JANT PHARMACAL CORPORATION | |
| 24 | 10743816000716 | BSP-122-35-01 | BSP-122-35-01 | BioSign® RC hCG S/U card; 35 Test kit; E Device; CE | BioSign® RC hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 25 | 10743816000709 | BSP-122-35-00 | BSP-122-35-00 | BioSign® RC hCG S/U card; 35 Test kit; CE | BioSign® RC hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 26 | 10743816000693 | BSP-122-35-02 | BSP-122-35-02 | StatusFirst™ hCG S/U card; for reader; LifeSign; 35 Test kit | StatusFirst™ hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 27 | 10743816000686 | BSP-120S-10-03 | BSP-120S-10-03 | Status™ hCG S/U card; LifeSign; 10 Test kit | Status™ hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 28 | 10743816000679 | BSP-120S-35-09 | BSP-120S-35-09 | BioSign® hCG S/U card; 35 Test kit; CE; E-device for Lifesign | BioSign® hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 29 | 10743816000662 | BSP-120S-10-01 | BSP-120S-10-01 | BioSign® hCG S/U card; 10 Test kit; CE | BioSign® hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 30 | 10743816000655 | BSP-120S-35-04 | BSP-120S-35-04 | BioSign® hCG S/U card; 35 Test kit; CE | BioSign® hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 31 | 10743816000648 | BSP-120S-12-00 | BSP-120S-12-00 | Status™ hCG S/U card; 12 Test sample kit | Status™ hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 32 | 10743816000631 | BSP-120S-35-01 | BSP-120S-35-01 | Status™ hCG S/U card; LifeSign; 35 Test kit | Status™ hCG S/U card | PRINCETON BIOMEDITECH CORPORATION |
| 33 | 10722355002832 | 3025 | For the qualitative detection of hCG in urine | AC&C DeTec hCG Pregnancy Test Device | IMMUNOSTICS COMPANY, INC | |
| 34 | 10722355002825 | 2010 | For the qualitative detection of hCG in urine | To Life HCG Pregnancy Test Strip | IMMUNOSTICS COMPANY, INC | |
| 35 | 10722355002061 | IHD/P-25OR | For the qualitative detection of hCG in urine | Detector hCG | IMMUNOSTICS COMPANY, INC | |
| 36 | 10722355002054 | IHS-25OR | For the qualitative detection of hCG in urine | Detector hCG Stick | IMMUNOSTICS COMPANY, INC | |
| 37 | 10722355001415 | IHDOTC | For the detection of hCG in urine to aid in the determination of pregnancy | Detector hCG | IMMUNOSTICS COMPANY, INC | |
| 38 | 10722355001385 | IDC-100 | For the qualitative detection of hCG in serum or urine | Detector hCG Combi | IMMUNOSTICS COMPANY, INC | |
| 39 | 10722355001378 | IDC-50 | For the qualitative detection of hCG in serum or urine | Detector hCG Combi | IMMUNOSTICS COMPANY, INC | |
| 40 | 10722355001361 | IDC-25 | For the qualitative detection of hCG in serum or urine | Detector hCG Combi | IMMUNOSTICS COMPANY, INC | |
| 41 | 10722355001354 | IHS-100 | For the qualitative detection of hCG in urine | Detector hCG Stick | IMMUNOSTICS COMPANY, INC | |
| 42 | 10722355001347 | IHS-50 | For the qualitative detection of hCG in urine | Detector hCG Stick | IMMUNOSTICS COMPANY, INC | |
| 43 | 10722355001330 | IHS-25 | For the qualitative detection of hCG in urine | Detector hCG Stick | IMMUNOSTICS COMPANY, INC | |
| 44 | 10722355001316 | IHD/P-50 | For the qualitative detection of hCG in urine | Detector hCG | IMMUNOSTICS COMPANY, INC | |
| 45 | 10722355001309 | IHD/P-25 | For the qualitative detection of hCG in urine | Detector hCG | IMMUNOSTICS COMPANY, INC | |
| 46 | 10722355001293 | IHD/P-100 | For the qualitative detection of hCG in urine | Detector hCG | IMMUNOSTICS COMPANY, INC | |
| 47 | 10304040024123 | 9004075 | 9004075 | One Step + hCG Combo Test | Henry Schein | HENRY SCHEIN, INC. |
| 48 | 10304040024116 | 9004074 | 9004074 | One Step hCG Urine Cass Test | Henry Schein | HENRY SCHEIN, INC. |
| 49 | 10304040024109 | 9004073 | 9004073 | One Step hCG Urine Cass Test | Henry Schein | HENRY SCHEIN, INC. |
| 50 | 10304040024093 | 9004072 | 9004072 | One Step + hCG Urine Strip Dip | Henry Schein | HENRY SCHEIN, INC. |