| 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 | 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 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00817415020963 | 788025 | 788025 | Strep A Test CLIA Waived 25/Box | Dealmed | DEALMED MEDICAL SUPPLIES LLC |
| 2 | 00816862023589 | PRE-STA-25 | PRE-STA-25 | 25-Strip; Strep A Throat Swab Test | Preview | WONDFO USA CO., LTD. |
| 3 | 00816862021059 | W39-S | 25-Strip; Strep A Throat Swab Test | Wondview | WONDFO USA CO., LTD. | |
| 4 | 00742860100116 | 148 | 148 | OSOM Ultra Strep A 5 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 5 | 00742860001499 | 149 | 149 | OSOM Ultra Strep A 50 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 6 | 00742860001475 | 147 | 147 | OSOM Ultra Strep A 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 7 | 00722066000014 | STR-15S25 | STR-15S25 | Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualita Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualitative detection of Group A Streptococcal antigen from throat swab specimens. | Rapid Response | BTNX INC |
| 8 | 00695684730406 | 73040 | A rapid dipstick test for the qualitative detection of group A streptococcal ant A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs. | STREPAIM | GERMAINE LABORATORIES, INC | |
| 9 | 00695684730253 | 73025 | A rapid dipstick test for the qualitative detection of group A streptococcal ant A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs. | STREPAIM | GERMAINE LABORATORIES, INC | |
| 10 | 00657498600023 | 6000-050 | 6000-050 | A rapid test for the qualitative detection of Strep A antigen in throat swab specimens. | QuSTICK™ Strep A | STANBIO LABORATORY, L.P. |
| 11 | 00657498600016 | 6000-025 | 6000-025 | A rapid test for the qualitative detection of Strep A antigen in throat swab specimens. | QuSTICK™ Strep A | STANBIO LABORATORY, L.P. |
| 12 | 00613647000557 | 4581455021 | 23900532 | SURE-VUE STREP A 27/PK | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 13 | 00613647000298 | 23-200-276 | 23200276 | Sure-Vue Signature Strep A | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 14 | 00612479242869 | 181-34125 | Status Strep A Flip | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 15 | 00612479202733 | 5003 | TEST, KIT STREP A DIPSTICK WAI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 16 | 00612479202726 | 4999 | TEST, KIT STREP A DIPSTICK WAI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 17 | 00382902560746 | 256074 | 256074 | BD Veritor™ Plus CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ Sys BD Veritor™ Plus CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ Plus Analyzer (Cat. No. 256066) | BD Veritor™ Plus CLIA-Waived Combo Pack | BECTON, DICKINSON AND COMPANY |
| 18 | 00382902560739 | 256073 | 256073 | BD Veritor™ System Laboratory Combo Pack Contains: 2xBD Veritor ™ Sy BD Veritor™ System Laboratory Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, Laboratory Kits (Cat. No. 256041) 1xBD Veritor ™ Plus Analyzer (Cat. No. 256066) | BD Veritor™ System Laboratory Combo Pack | BECTON, DICKINSON AND COMPANY |
| 19 | 00382902560715 | 256071 | 256071 | BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ S BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055) | BD Veritor™ System CLIA-Waived Combo Pack | BECTON, DICKINSON AND COMPANY |
| 20 | 00382902560708 | 256070 | 256070 | BD Veritor™ Plus Laboratory Combo Pack Contains: 2xBD Veritor ™ Syst BD Veritor™ Plus Laboratory Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, Laboratory Kits (Cat. No. 256041) 1xBD Veritor ™ System Reader (Cat. No. 256055) | BD Veritor™ Plus Laboratory Combo Pack | BECTON, DICKINSON AND COMPANY |
| 21 | 00382902560401 | 256040 | 256040 | BD Veritor™ System For Rapid Detection of Group A Strep Contains: 30 Strep BD Veritor™ System For Rapid Detection of Group A Strep Contains: 30 Strep A Devices, 30 GAS Reagent 2 in unitized tubes, 30 individually wrapped, sterile throat swabs, one 4 mL dropper bottle GAS Reagent 1, one each of positive and negative control swabs | BD Veritor™ System For Rapid Detection of Group A Strep - CLIA waived kit | BECTON, DICKINSON AND COMPANY |
| 22 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | QuickVue | QUIDEL CORPORATION |
| 23 | 30014613202769 | 20276 | 20276 | Sofia Strep A+ 25T | Sofia | QUIDEL CORPORATION |
| 24 | 30014613202745 | 20274 | 20274 | Sofia Strep A+ 25T, US | Sofia | QUIDEL CORPORATION |
| 25 | 30014613202530 | 20253 | 20253 | Sofia Strep A 25T, US | Sofia | QUIDEL CORPORATION |
| 26 | 30014613202318 | 20231 | 20231 | Sofia Strep A 25T | Sofia | QUIDEL CORPORATION |
| 27 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | QuickVue | QUIDEL CORPORATION |
| 28 | 30014613201250 | 20125 | 20125 | QkVue Strep A Dpstk 25T | QuickVue | QUIDEL CORPORATION |
| 29 | 30014613201083 | 20108 | 20108 | QkVue Strep A Dpstk 50T | QuickVue | QUIDEL CORPORATION |
| 30 | 30014613003458 | 00345 | 00345 | QkVue InLine Strep A Ctrl Set | QuickVue In-Line | QUIDEL CORPORATION |
| 31 | 20885380183628 | CH27 | CH27 | CH27 - Strep A Dipstick Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 32 | 20885380106955 | B1077-40 | B1077-40 | STREP A CASSETTE RAPID TEST | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 33 | 20885380059138 | B1077-30 | B1077-30 | Strep A Dipstick Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 34 | 15099590625955 | 395161 | 395161 | ICON SC Strep A Kit, 25 Tests | Icon | BECKMAN COULTER, INC. |
| 35 | 15099590625931 | 395098 | 395098 | ICON DS STREP A, 25 TEST BOX | Icon | BECKMAN COULTER, INC. |
| 36 | 10859035006221 | 46050 | Wampole ColorCard® Streptozyme® | ALERE NORTH AMERICA, LLC | ||
| 37 | 10815845020055 | 01P46-50 | Signify® | ALERE SAN DIEGO, INC. | ||
| 38 | 10815845020031 | 92001 | Acceava® | ALERE SAN DIEGO, INC. | ||
| 39 | 10815845020024 | 92002 | Clearview® | ALERE SAN DIEGO, INC. | ||
| 40 | 10763924513199 | ID513 | Strep A Rapid Test Strip (Throat Swab) | Accutest Value+ Strep A Rapid Test Strip | JANT PHARMACAL CORPORATION | |
| 41 | 10743816000907 | BSP-185-30-06 | BSP-185-30-06 | BioStrep® A strip; 30 Test kit; CE; for LifeSign (Infolab) | BioStrep® A | PRINCETON BIOMEDITECH CORPORATION |
| 42 | 10743816000891 | BSP-185-30-04 | BSP-185-30-04 | BioStrep® A strip; 30 Test kit; CE | BioStrep® A | PRINCETON BIOMEDITECH CORPORATION |
| 43 | 10743816000884 | BSP-185-12-00 | BSP-185-12-00 | Status Strep A strip; 12 Test sample kit | Status Strep A strip | PRINCETON BIOMEDITECH CORPORATION |
| 44 | 10743816000877 | BSP-185-30-01 | BSP-185-30-01 | Status Strep A strip; 30 Test kit | Status Strep A strip | PRINCETON BIOMEDITECH CORPORATION |
| 45 | 10743816000860 | BSP-185-05-00 | BSP-185-05-00 | Status Strep A Plus; 5 Test kit (5 Test Strip Canister) | Status Strep A Plus | PRINCETON BIOMEDITECH CORPORATION |
| 46 | 10743816000853 | BSP-185-50-01 | BSP-185-50-01 | Status Strep A Plus; 50 Test kit (2 x 25 Test Strip Canister) | Status Strep A Plus | PRINCETON BIOMEDITECH CORPORATION |
| 47 | 10743816000846 | BSP-182-12-00 | BSP-182-12-00 | Status Strep A card; Flip cassette; 12 Test sample kit | Status Strep A Flip | PRINCETON BIOMEDITECH CORPORATION |
| 48 | 10743816000839 | BSP-182-05-00 | BSP-182-05-00 | Status Strep A card; Flip cassette; 5 Test kit | Status Strep A Flip | PRINCETON BIOMEDITECH CORPORATION |
| 49 | 10743816000822 | BSP-182-25-03 | BSP-182-25-03 | BioSign® Strep A card; Flip cassette; 25 Test kit; for LifeSign (Infolab) | BioSign® Strep A Flip | PRINCETON BIOMEDITECH CORPORATION |
| 50 | 10743816000815 | BSP-182-25-02 | BSP-182-25-02 | BioSign® Strep A card; Flip cassette; 25 Test kit | BioSign® Strep A card | PRINCETON BIOMEDITECH CORPORATION |