| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 14560189212463 | N/A | LCP | Assay, Glycosylated Hemoglobin | ST AIA-PACK HbA1c | |||
| 2 | 14560189212135 | N/A | KHQ | Radioassay, Triiodothyronine Uptake | ST AIA-PACK T-U | |||
| 3 | 14560189212005 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK RBC FOLATE | |||
| 4 | 04560189211827 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | AIA-PACK PRL CALIBRATOR SET | ||
| 5 | 04560189211407 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI CALIBRATOR SET | ||
| 6 | 04560189211292 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Sample Diluting Solution | ||
| 7 | 04560189212299 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK bHCG Calibration Verification Test Set | ||
| 8 | 04560189212022 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK RBC FOLATE HEMOLYZING REAGENT SET | ||
| 9 | 14560189212739 | N/A | CHP | Radioimmunoassay, Estradiol | ST AIA-PACK hsE2 | |||
| 10 | 14560189212517 | N/A | CKG | Radioimmunoassay, Acth | ST AIA-PACK ACTH | |||
| 11 | 14560189212104 | n/a | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | ST AIA-PACK PA | |||
| 12 | 14560189211916 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK Folate | |||
| 13 | 04560189211940 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK Floate Sample Diluting Solution | ||
| 14 | 14560189211879 | N/A | CDD | Radioassay, Vitamin B12 | AIA-PACK B12 | |||
| 15 | 04560189211889 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Calibrator Set | ||
| 16 | 04560189211650 | N/A | CEP | Radioimmunoassay, Luteinizing Hormone | 1 | ST AIA-PACK LH II CALIBRATOR SET | ||
| 17 | 04560189211445 | N/A | CFL | Radioimmunoassay, Human Growth Hormone | 1 | AIA-PACK HGH Calibrator Set | ||
| 18 | 04560189211391 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI SAMPLE DILUTING SOLUTION | ||
| 19 | 04560189211308 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Calibrator Set | ||
| 20 | 14560189210834 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | ST AIA-PACK PRL | |||
| 21 | 14560189210483 | N/A | DBF | Ferritin, Antigen, Antiserum, Control | ST AIA-PACK FER | |||
| 22 | 14560189210391 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | ST AIA-PACK FSH | |||
| 23 | 14560189210360 | N/A | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | ST AIA-PACK TSH | ||
| 24 | 14560189210285 | N/A | CDP | Radioimmunoassay, Total Triiodothyronine | ST AIA-PACK FT3 | |||
| 25 | 14560189210117 | N/A | MMI | Immunoassay Method, Troponin Subunit | ST AIA-PACK cTnI 2 | |||
| 26 | 04560189212817 | N/A | LPS | Urinary Homocystine (Nonquantitative) Test System | 2 | ST AIA-PACK Homocysteine Pretreatment Set | ||
| 27 | 04560189212800 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK Homocysteine Control Set | ||
| 28 | 04560189212596 | N/A | JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | ST AIA-PACK DHEA-S Sample Diluting Solution | ||
| 29 | 04560189212190 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Cystatin C Calibatator Set | ||
| 30 | 04560189211285 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | ST AIA-PACK E2 CALIBRATOR SET | ||
| 31 | 04560189211278 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | AIA-PACK E2 Sample Diluting Solution | ||
| 32 | 04560189211148 | N/A | LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | AIA-PACK CA 125 Calibrator Set | ||
| 33 | 04560189211124 | N/A | NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pa System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 | AIA-PACK CA 19-9 Sample Diluting Solution | ||
| 34 | 04560189211100 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | 2 | AIA-PACK 27.29 Calibrator Set | ||
| 35 | 14560189212173 | N/A | NDY | Test, Cystatin C | ST AIA-PACK Cystatin C | |||
| 36 | 04560189211902 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Sample Diluting Solution | ||
| 37 | 04560189211780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | 2 | AIA-PACK CEA Sample Diluting Solution | ||
| 38 | 04560189211421 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Intact PTH CALIBRATOR SET | ||
| 39 | 04560189211414 | N/A | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION | ||
| 40 | 04560189211353 | N/A | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | AIA-PACK βHCG Calibrator Set | ||
| 41 | 14560189210780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | ST AIA-PACK CEA | |||
| 42 | 14560189213125 | N/A | MRG | System, Test, Vitamin D | ST AIA-PACK 25-OH Vitamin D | |||
| 43 | 14560189210179 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | ST AIA-PACK 27.29 | |||
| 44 | 14560189210155 | N/A | DGC | Ige, Antigen, Antiserum, Control | ST AIA-PACK IgEII | |||
| 45 | 04560189284005 | N/A | KHO | Fluorometer, For Clinical Use | 1 | 9tray Sorter | ||
| 46 | 04560189283992 | AIA-900 | KHO | Fluorometer, For Clinical Use | 1 | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | ||
| 47 | 04560189283619 | N/A | LCP | Assay, Glycosylated Hemoglobin | 2 | G8 Variant Elution Buffer HSi No.2 (S) | ||
| 48 | 04560189213395 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK PROG II CALIBRATOR SET | ||
| 49 | 04560189213371 | N/A | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | ||
| 50 | 04560189213333 | N/A | JIT | Calibrator, Secondary | 2 | AIA-PACK C-Peptide II Calibrator Set |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00846841060700 | HCG(3mm) | ONE STEP HCG URINE PREGNANCY TEST (STRIP) | ChoiceMMed | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. | |
| 2 | 00841824102248 | F2-CK04 | F2-CK04 | hCG Pregnancy Urine/Serum Test Cassette (4mm), 25/plain white box | NA | W.H.P.M. INC. |
| 3 | 00841824102231 | F2-DK04 | F2-DK04 | hCG Pregnancy Urine/Serum Test Strip (4mm), 50 /plain white box | NA | W.H.P.M. INC. |
| 4 | 00841824102217 | F1-DK04 | F1-DK04 | hCG Pregnancy Urine Test Strip (4 mm ), 50 /plain white box | NA | W.H.P.M. INC. |
| 5 | 00841824102194 | F1-CK04 | F1-CK04 | WH ACCU hCG Pregnancy Urine Test Cassette (4mm), 40 /colored WH box | WH Accu Test™ | W.H.P.M. INC. |
| 6 | 00841824102163 | F1-CK04/2 | F1-CK04/2 | hCG Pregnancy Urine Test Cassette (4mm) | NA | W.H.P.M. INC. |
| 7 | 00841824102033 | F1-C04-100 | F1-C04-100 | hCG Pregnancy Urine Test Cassette (4mm Strip) Sealed in Plain White Pouch, 100pcs/bag | NA | W.H.P.M. INC. |
| 8 | 00841824101814 | F1-DC04-50 | F1-DC04-50 | hCG Pregnancy Urine Test Dip Card (4mm Strip) Sealed in Plain White Pouch, 50pcs/bag | N/A | W.H.P.M. INC. |
| 9 | 00840239028181 | RAP-2818 | RAP-2818 | This is a test for the qualitative detection of human Chorionic Gonadotropin (HC This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urine. | HCG dipstick Test | DRG INTERNATIONAL INC |
| 10 | 00840239017833 | EIA-1783 | EIA-1783 | 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. | Human Chorionic Gonadotropin (hCG) ELISA | DRG INTERNATIONAL INC |
| 11 | 00817830020272 | 07RD7002 | 07RD7002 | HCG TEST CARD | RAPID DIAGNOSTICS HCG TEST CARD | RAPID DIAGNOSTICS INC |
| 12 | 00817830020265 | 07RD7001 | 07RD7001 | HCG TEST STRIP | RAPID DIAGNOSTICS HCG TEST STRIP | RAPID DIAGNOSTICS INC |
| 13 | 00817763021933 | F1-ST25 | F1-D04 | First Sign hCG Pregnancy Urine Test Strip (4mm); 25Pcs/Box for Hemosure | First Sign® | HEMOSURE INC. |
| 14 | 00817415021069 | 788525 | 788525 | Pregnancy hCG Test Cassette, 25/Box | Dealmed | DEALMED MEDICAL SUPPLIES LLC |
| 15 | 00816870020976 | 3325-300 | 3325-300B | Monobind AccuBind hCG Rapid ELISA Kit - 192 Wells | MONOBIND, INC. | |
| 16 | 00816870020969 | 3325-300 | 3325-300A | Monobind AccuBind hCG Rapid ELISA Kit - 96 Wells | MONOBIND, INC. | |
| 17 | 00816862022216 | SW1-S | 1-Strip; hCG Pregnancy Test SCI | Wondfo | WONDFO USA CO., LTD. | |
| 18 | 00816862022179 | HCG-PRE-OTC10 | 1-Midstreams; hCG Pregnancy Midstream Test Retail Box 1 Pcs Preview 10 MIU | Preview | WONDFO USA CO., LTD. | |
| 19 | 00816862022148 | SW1-C | 1-Panel Cassette; hCG Pregnancy Test SCI | Wondfo | WONDFO USA CO., LTD. | |
| 20 | 00816862021905 | W1-S3 | 1 Strip; hCG Serum/Urine Test Strip | Wondfo | WONDFO USA CO., LTD. | |
| 21 | 00816862021721 | PRE-HCG-25SE | Preview Early Result Test Strip | Preview | WONDFO USA CO., LTD. | |
| 22 | 00816862021615 | WS-H20L50B | 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test | Wondfo | WONDFO USA CO., LTD. | |
| 23 | 00816862021516 | W1-S10 | 25-Strip; hCG Pregnancy Test 10mIU | Wondfo | WONDFO USA CO., LTD. | |
| 24 | 00816862021509 | PRE-HCG-25C | Preview hCG Pregnancy Test Cassette | Preview | WONDFO USA CO., LTD. | |
| 25 | 00816862021493 | PRE-HCG-25S | Preview hCG Pregnancy Test Strip | Preview | WONDFO USA CO., LTD. | |
| 26 | 00816862021349 | W1-S25 | 25-Strip; hCG Pregnancy Test | Wondfo | WONDFO USA CO., LTD. | |
| 27 | 00816862020960 | WMII-H2L10 | WMII-H2L10 | 2+10 Mini-Midstream Combo; 2 hCG Pregnancy Test + 10 LH Ovulation Test | Preview | WONDFO USA CO., LTD. |
| 28 | 00816862020953 | WS-H20L50 | WS-H20L50 | 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test | Wondfo | WONDFO USA CO., LTD. |
| 29 | 00816862020946 | W1-S20 | W1-S20 | 20-Strip; hCG Pregnancy Test | Wondfo | WONDFO USA CO., LTD. |
| 30 | 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. |
| 31 | 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 |
| 32 | 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. |
| 33 | 00742860100208 | 1004 | 1004 | OSOM Ultra hCG 25T Kit | OSOM Ultra hCG 25T Kit | SEKISUI DIAGNOSTICS, LLC |
| 34 | 00742860100154 | 101-10 | 101-10 | OSOM hCG Urine 10 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 35 | 00742860100086 | 134 | 134 | OSOM hCG Urine Ctrl Set | SEKISUI DIAGNOSTICS, LLC | |
| 36 | 00742860100079 | 102W-5 | 102W-5 | OSOM hCG Card 5 Test kit | SEKISUI DIAGNOSTICS, LLC | |
| 37 | 00742860100031 | 755425 | 755425 | HCG COMBO, MERIDIAN 25 test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 38 | 00742860001246 | 124 | 124 | OSOM Combo hCG 25 Test kit | SEKISUI DIAGNOSTICS, LLC | |
| 39 | 00742860001024 | 102W | 102W | OSOM hCG Card 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 40 | 00742860001017 | 101 | 101 | OSOM hCG Urine 50 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 41 | 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 |
| 42 | 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 |
| 43 | 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 |
| 44 | 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 |
| 45 | 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 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 | |
| 49 | 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 | |
| 50 | 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 |