| 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 | 00817830020272 | 07RD7002 | 07RD7002 | HCG TEST CARD | RAPID DIAGNOSTICS HCG TEST CARD | RAPID DIAGNOSTICS INC |
| 2 | 00817830020265 | 07RD7001 | 07RD7001 | HCG TEST STRIP | RAPID DIAGNOSTICS HCG TEST STRIP | RAPID DIAGNOSTICS INC |
| 3 | 00817763021933 | F1-ST25 | F1-D04 | First Sign hCG Pregnancy Urine Test Strip (4mm); 25Pcs/Box for Hemosure | First Sign® | HEMOSURE INC. |
| 4 | 00817415021069 | 788525 | 788525 | Pregnancy hCG Test Cassette, 25/Box | Dealmed | DEALMED MEDICAL SUPPLIES LLC |
| 5 | 00816870020976 | 3325-300 | 3325-300B | Monobind AccuBind hCG Rapid ELISA Kit - 192 Wells | MONOBIND, INC. | |
| 6 | 00816870020969 | 3325-300 | 3325-300A | Monobind AccuBind hCG Rapid ELISA Kit - 96 Wells | MONOBIND, INC. | |
| 7 | 00816862022216 | SW1-S | 1-Strip; hCG Pregnancy Test SCI | Wondfo | WONDFO USA CO., LTD. | |
| 8 | 00816862022179 | HCG-PRE-OTC10 | 1-Midstreams; hCG Pregnancy Midstream Test Retail Box 1 Pcs Preview 10 MIU | Preview | WONDFO USA CO., LTD. | |
| 9 | 00816862022148 | SW1-C | 1-Panel Cassette; hCG Pregnancy Test SCI | Wondfo | WONDFO USA CO., LTD. | |
| 10 | 00816862021905 | W1-S3 | 1 Strip; hCG Serum/Urine Test Strip | Wondfo | WONDFO USA CO., LTD. | |
| 11 | 00816862021721 | PRE-HCG-25SE | Preview Early Result Test Strip | Preview | WONDFO USA CO., LTD. | |
| 12 | 00816862021615 | WS-H20L50B | 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test | Wondfo | WONDFO USA CO., LTD. | |
| 13 | 00816862021516 | W1-S10 | 25-Strip; hCG Pregnancy Test 10mIU | Wondfo | WONDFO USA CO., LTD. | |
| 14 | 00816862021509 | PRE-HCG-25C | Preview hCG Pregnancy Test Cassette | Preview | WONDFO USA CO., LTD. | |
| 15 | 00816862021493 | PRE-HCG-25S | Preview hCG Pregnancy Test Strip | Preview | WONDFO USA CO., LTD. | |
| 16 | 00816862021349 | W1-S25 | 25-Strip; hCG Pregnancy Test | Wondfo | WONDFO USA CO., LTD. | |
| 17 | 00816862020960 | WMII-H2L10 | WMII-H2L10 | 2+10 Mini-Midstream Combo; 2 hCG Pregnancy Test + 10 LH Ovulation Test | Preview | WONDFO USA CO., LTD. |
| 18 | 00816862020953 | WS-H20L50 | WS-H20L50 | 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test | Wondfo | WONDFO USA CO., LTD. |
| 19 | 00816862020946 | W1-S20 | W1-S20 | 20-Strip; hCG Pregnancy Test | Wondfo | WONDFO USA CO., LTD. |
| 20 | 00816467020112 | hCG Diluent | 25000036 | Used to dilute the sample if the test result reads outside the assay range. Max Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample. | FastPack® IP hCG Diluent Kit (25) | QUALIGEN INC. |
| 21 | 00816036025968 | STP-10-0 | STP-10-0 | Single STATDIP Pregnancy Midstream 10 mIU/mL, 1 Test per Box | STATTEST Home Pregnancy Test | MICRO DISTRIBUTING, L.C |
| 22 | 00811727013255 | F1027-96 | F1027-96 | The hCG ELISA is intended for the quantitative determination of human chorionic The hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. 96 Tests. | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 23 | 00742860100208 | 1004 | 1004 | OSOM Ultra hCG 25T Kit | OSOM Ultra hCG 25T Kit | SEKISUI DIAGNOSTICS, LLC |
| 24 | 00742860100154 | 101-10 | 101-10 | OSOM hCG Urine 10 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 25 | 00742860100086 | 134 | 134 | OSOM hCG Urine Ctrl Set | SEKISUI DIAGNOSTICS, LLC | |
| 26 | 00742860100079 | 102W-5 | 102W-5 | OSOM hCG Card 5 Test kit | SEKISUI DIAGNOSTICS, LLC | |
| 27 | 00742860100031 | 755425 | 755425 | HCG COMBO, MERIDIAN 25 test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 28 | 00742860001246 | 124 | 124 | OSOM Combo hCG 25 Test kit | SEKISUI DIAGNOSTICS, LLC | |
| 29 | 00742860001024 | 102W | 102W | OSOM hCG Card 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 30 | 00742860001017 | 101 | 101 | OSOM hCG Urine 50 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 31 | 00722066003244 | HCG-3S100 | HCG-3S100 | Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qualitativ Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qualitative detection of Human Chorionic Gonadotropin in urine/ serum. | Rapid Response | BTNX INC |
| 32 | 00722066001202 | HCG-1S100 | HCG-1S100 | Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qulitative Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qulitative detection of Human Chorionic Gonadotropin in urine. | Rapid Response | BTNX INC |
| 33 | 00722066001042 | HCG-1S50 | HCG-1S50 | Rapid Response hCG Pregnancy Test Strips - 50 tests/ kit are for the qulitative Rapid Response hCG Pregnancy Test Strips - 50 tests/ kit are for the qulitative detection of Human Chorionic Gonadotropin in urine. | Rapid Response | BTNX INC |
| 34 | 00722066000274 | HCG-1C25 | HCG-1C25 | Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitat Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine. | Rapid Response | BTNX INC |
| 35 | 00722066000267 | HCG-3C25 | HCG-3C25 | Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitat Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitative detection of Human Chorionic Gonadotropin in urine/ serum, | Rapid Response | BTNX INC |
| 36 | 00722066000229 | HCG-1C50 | HCG-1C50 | Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitat Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine. | Rapid Response | BTNX INC |
| 37 | 00722066000205 | HCG-3C50 | HCG-3C50 | Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitat Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of Human Chlorionic Gonadotropin in urine/ serum. | Rapid Response | BTNX INC |
| 38 | 00695684977368 | 97736 | For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in serum or urine. | ONE-STEP PLUS PREGNANCY | GERMAINE LABORATORIES, INC | |
| 39 | 00695684977344 | 97734 | For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in serum or urine. | ONE PLUS PREGNANCY | GERMAINE LABORATORIES, INC | |
| 40 | 00695684977337 | 97733 | For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in serum or urine. | AIMSTEP COMBO PREGNANCY | GERMAINE LABORATORIES, INC | |
| 41 | 00695684977320 | 97732 | For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in serum or urine. | AIMSTEP COMBO PREGNANCY | GERMAINE LABORATORIES, INC | |
| 42 | 00695684977306 | 97730 | For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in serum or urine. | AIMSTEP COMBO PREGNANCY | GERMAINE LABORATORIES, INC | |
| 43 | 00695684971007 | 97100 | Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine. | AIMSTEP PREGNANCY | GERMAINE LABORATORIES, INC | |
| 44 | 00695684970505 | 97050 | Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine. | AIMSTEP PREGNANCY | GERMAINE LABORATORIES, INC | |
| 45 | 00695684970383 | 97038 | Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine. | FYI URINE PREGNANCY | GERMAINE LABORATORIES, INC | |
| 46 | 00695684970376 | 97037 | Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine. | QUICK & CLEAR II PREGNANCY | GERMAINE LABORATORIES, INC | |
| 47 | 00695684970369 | 97036 | Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine. | ONESTEP PREGNANCY | GERMAINE LABORATORIES, INC | |
| 48 | 00695684970321 | 97032 | Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine. | AIMSTEP PREGNANCY | GERMAINE LABORATORIES, INC | |
| 49 | 00695684970307 | 97030 | Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine. | AIMSTEP PREGNANCY | GERMAINE LABORATORIES, INC | |
| 50 | 00695684970253 | 97025 | Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine. | AIMSTEP PREGNANCY | GERMAINE LABORATORIES, INC |