No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30014613336754 | RPS-ID-20-U | RPS-ID-20-U | InflammaDry | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | InflammaDry |
2 | 30014613336747 | RPS-ID-20 | RPS-ID-20 | InflammaDry | PFQ,JJX | MMP-9 test system,Single (specified) analyte controls (assayed and unassayed) | 1 | InflammaDry |
3 | 30014613336402 | Trichomonas Assay | M304.U | SolanaTrichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
4 | 30014613336396 | Trichomonas Assay | M304.S | Solana Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
5 | 30014613336082 | Group A Strep Assay | M301 | Solana GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Solana |
6 | 30014613335580 | C1-Inhibitor | A037 | MicroVue C1-Inhibitor Plus EIA | DBA | COMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
7 | 30014613335573 | Bp Plus EIA | A027 | Kit, Quidel Bb Plus | JZH | FACTOR B, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
8 | 30014613335566 | CH50 Eq EIA | A018 | MicroVue CH50 Eq EIA | DAE | COMPLEMENT C9, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
9 | 30014613335559 | CIC-C1q Controls | A013 | MicroVue CIC-C1q Ctrls | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
10 | 30014613335542 | CIC-Raji EIA | A002 | MicroVue CIC-Raji EIA | CZY | COMPLEMENT C1S, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
11 | 30014613335535 | CIC-C1q EIA | A001 | MicroVue CIC-C1q EIA | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
12 | 30014613333951 | Vitamin D EIA | 8046 | MicroVue Vitamin D EIA | MRG | SYSTEM, TEST, VITAMIN D | 2 | MicroVue |
13 | 30014613333944 | PTH EIA | 8044 | MicroVue PTH EIA | CEW | RADIOIMMUNOASSAY, PARATHYROID HORMONE | 2 | MicroVue |
14 | 30014613333937 | Calcitonin EIA | 8043 | MicroVue Calcitonin EIA | JKR | RADIOIMMUNOASSAY, CALCITONIN | 2 | MicroVue |
15 | 30014613333920 | BAP EIA | 8012 | MicroVue BAP EIA | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | MicroVue |
16 | 30014613333913 | PYD EIA | 8010 | Kit, McVu PYD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
17 | 30014613333906 | DPD EIA | 8007 | Kit, McVu DPD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
18 | 30014613311140 | Parainfluenza Virus Assay | M114 | Lyra Parainfluenza Assay | OOU | Parainfluenza multiplex nucleic acid assay | 2 | Lyra |
19 | 30014613311133 | Adenovirus Assay | M113 | Lyra Adenovirus Assay | OCC | Respiratory virus panel nucleic acid assay system | 2 | Lyra |
20 | 30014613311126 | Direct Strep Assay | M112 | Lyra Direct Strep Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Lyra |
21 | 30014613311058 | Direct C. difficile Assay | M105 | Lyra Direct CDIFF Assay | OZN,OOI | C.Difficile toxin gene amplification assay,real time Nucleic acid amplification system | 2 | Lyra |
22 | 30014613311027 | Direct HSV 1+2/VZV Assay | M102 | Lyra Direct HSV 1+2/VZV Assay | PGI | Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutane Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutaneous lesion samples | 2 | Lyra |
23 | 30014613202783 | 20278 | 20278 | Solana instrument | NSU | Instrumentation for clinical multiplex test systems | 2 | Solana |
24 | 30014613003458 | 00345 | 00345 | QkVue InLine Strep A Ctrl Set | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
25 | 30014613003434 | 00343 | 00343 | QkVue InLine Strep A 25T | GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
26 | 30014613336686 | RPS-AD | RPS-AD | AdenoPlus | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | AdenoPlus |
27 | 30014613339724 | 20402 | 20402 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
28 | 30014613339687 | 20399 | 20399 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
29 | 30014613339670 | 20398 | 20398 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
30 | 30014613339373 | 20387 | 20387 | QuickVue® SARS Antigen Test | QuickVue | |||
31 | 30014613331469 | 20189 | 20189 | QkVue Flu A+B 20K-T, Bulk | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
32 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
33 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | LYR | Helicobacter pylori | 1 | QuickVue |
34 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | LYR | Helicobacter pylori | 1 | QuickVue |
35 | 30014613312123 | Group A Strep Assay | M212 | AmpliVue GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | AmpliVue |
36 | 30014613312116 | Trichomonas Assay | M211 | AmpliVue Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | AmpliVue |
37 | 30014613312109 | HSV 1+2 Assay | M210 | AmpliVue HSV 1+2 Assay | OQO | Herpes simplex virus nucleic acid amplification assay | 2 | AmpliVue |
38 | 30014613312093 | Bordetella Assay | M209 | AmpliVue Bordetella Assay | OZZ | Bordetella pertussis dna assay system | 2 | AmpliVue |
39 | 30014613312024 | GBS Assay | M202 | AmpliVue GBS Assay | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | AmpliVue |
40 | 30014613312017 | C. difficile Assay | M201 | AmpliVue CDiff Assay | OZN | C.Difficile toxin gene amplification assay | 2 | AmpliVue |
41 | 30014613202226 | 20222 | 20222 | QkVue RSV 10, 25T | GQG | ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
42 | 30014613202059 | iFOB Test | 20205 | QuickVue iFOB Test Dev Kit 100T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
43 | 30014613202042 | iFOB Test | 20204 | QuickVue iFOB Collect Kit 40T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
44 | 30014613202011 | iFOB Test | 20201 | QuickVue iFOB Tray Pack 50T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
45 | 30014613201977 | 20197 | 20197 | QkVue iFOB Control Set | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
46 | 30014613201960 | iFOB Test | 20196 | QuickVue iFOB Collect Kit 10T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
47 | 30014613201946 | iFOB Test | 20194 | QuickVue iFOB 20T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
48 | 30014613201939 | 20193 | 20193 | QkVue RSV 20T | MCE,GQG | RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRA RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
49 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
50 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00863545000306 | N/A | dBest | AMERITEK, INC. | ||
2 | 00858022006216 | 8001-50 | 8001-50 | Box of 50 cartridges/tests | AdexusDx hCG Test | NOWDIAGNOSTICS, INC. |
3 | 00858022006209 | 8001-25 | 8001-25 | Box of 25 cartridges/tests | AdexusDx hCG Test | NOWDIAGNOSTICS, INC. |
4 | 00858022006193 | 8001-1 | 8001-1 | Box of one test cartridge | AdexusDx hCG Test | NOWDIAGNOSTICS, INC. |
5 | 00857338006330 | F2-CT25C | F2-CT25C | First Sign hCG Pregnancy Urine/Serum Test Cassette (4mm); 25Pcs/Box for Hemosure | First Sign® | HEMOSURE INC. |
6 | 00857338006224 | F1-CT25U | F1-CT25U | First Sign hCG Pregnancy Urine Test Cassette (4mm); 25Pcs/Box for Hemosure | First Sign® | HEMOSURE INC. |
7 | 00857338006217 | F2-CT25C | F2-CT25C | First Sign hCG Pregnancy Urine/Serum Test Cassette (4mm); 25Pcs/Box for Hemosure | First Sign | HEMOSURE INC. |
8 | 00855574005384 | HCG25 | HCG, Immunochromatographic Test | Poly stat | POLYMEDCO, INC. | |
9 | 00853691007205 | 1 | FHC-202 | Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette | Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette | ACRO BIOTECH INC |
10 | 00850392007275 | BC-1027 | BC-1027 | The BioCheck hCG EIA Test Kit is intended for the quantitative determination of The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. | BioCheck hCG EIA Test Kit | BIOCHECK, INC. |
11 | 00850011007174 | TNR HCGCOMBO | TNR HCGCOMBO | Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,P Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |
12 | 00846841060700 | HCG(3mm) | ONE STEP HCG URINE PREGNANCY TEST (STRIP) | ChoiceMMed | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. | |
13 | 00841824102248 | F2-CK04 | F2-CK04 | hCG Pregnancy Urine/Serum Test Cassette (4mm), 25/plain white box | NA | W.H.P.M. INC. |
14 | 00841824102231 | F2-DK04 | F2-DK04 | hCG Pregnancy Urine/Serum Test Strip (4mm), 50 /plain white box | NA | W.H.P.M. INC. |
15 | 00841824102217 | F1-DK04 | F1-DK04 | hCG Pregnancy Urine Test Strip (4 mm ), 50 /plain white box | NA | W.H.P.M. INC. |
16 | 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. |
17 | 00841824102163 | F1-CK04/2 | F1-CK04/2 | hCG Pregnancy Urine Test Cassette (4mm) | NA | W.H.P.M. INC. |
18 | 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. |
19 | 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. |
20 | 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 |
21 | 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 |
22 | 00817830020272 | 07RD7002 | 07RD7002 | HCG TEST CARD | RAPID DIAGNOSTICS HCG TEST CARD | RAPID DIAGNOSTICS INC |
23 | 00817830020265 | 07RD7001 | 07RD7001 | HCG TEST STRIP | RAPID DIAGNOSTICS HCG TEST STRIP | RAPID DIAGNOSTICS INC |
24 | 00817763021933 | F1-ST25 | F1-D04 | First Sign hCG Pregnancy Urine Test Strip (4mm); 25Pcs/Box for Hemosure | First Sign® | HEMOSURE INC. |
25 | 00817415021069 | 788525 | 788525 | Pregnancy hCG Test Cassette, 25/Box | Dealmed | DEALMED MEDICAL SUPPLIES LLC |
26 | 00816870020976 | 3325-300 | 3325-300B | Monobind AccuBind hCG Rapid ELISA Kit - 192 Wells | MONOBIND, INC. | |
27 | 00816870020969 | 3325-300 | 3325-300A | Monobind AccuBind hCG Rapid ELISA Kit - 96 Wells | MONOBIND, INC. | |
28 | 00816862022216 | SW1-S | 1-Strip; hCG Pregnancy Test SCI | Wondfo | WONDFO USA CO., LTD. | |
29 | 00816862022179 | HCG-PRE-OTC10 | 1-Midstreams; hCG Pregnancy Midstream Test Retail Box 1 Pcs Preview 10 MIU | Preview | WONDFO USA CO., LTD. | |
30 | 00816862022148 | SW1-C | 1-Panel Cassette; hCG Pregnancy Test SCI | Wondfo | WONDFO USA CO., LTD. | |
31 | 00816862021905 | W1-S3 | 1 Strip; hCG Serum/Urine Test Strip | Wondfo | WONDFO USA CO., LTD. | |
32 | 00816862021721 | PRE-HCG-25SE | Preview Early Result Test Strip | Preview | WONDFO USA CO., LTD. | |
33 | 00816862021615 | WS-H20L50B | 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test | Wondfo | WONDFO USA CO., LTD. | |
34 | 00816862021516 | W1-S10 | 25-Strip; hCG Pregnancy Test 10mIU | Wondfo | WONDFO USA CO., LTD. | |
35 | 00816862021509 | PRE-HCG-25C | Preview hCG Pregnancy Test Cassette | Preview | WONDFO USA CO., LTD. | |
36 | 00816862021493 | PRE-HCG-25S | Preview hCG Pregnancy Test Strip | Preview | WONDFO USA CO., LTD. | |
37 | 00816862021349 | W1-S25 | 25-Strip; hCG Pregnancy Test | Wondfo | WONDFO USA CO., LTD. | |
38 | 00816862020960 | WMII-H2L10 | WMII-H2L10 | 2+10 Mini-Midstream Combo; 2 hCG Pregnancy Test + 10 LH Ovulation Test | Preview | WONDFO USA CO., LTD. |
39 | 00816862020953 | WS-H20L50 | WS-H20L50 | 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test | Wondfo | WONDFO USA CO., LTD. |
40 | 00816862020946 | W1-S20 | W1-S20 | 20-Strip; hCG Pregnancy Test | Wondfo | WONDFO USA CO., LTD. |
41 | 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. |
42 | 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 |
43 | 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. |
44 | 00742860100208 | 1004 | 1004 | OSOM Ultra hCG 25T Kit | OSOM Ultra hCG 25T Kit | SEKISUI DIAGNOSTICS, LLC |
45 | 00742860100154 | 101-10 | 101-10 | OSOM hCG Urine 10 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
46 | 00742860100086 | 134 | 134 | OSOM hCG Urine Ctrl Set | SEKISUI DIAGNOSTICS, LLC | |
47 | 00742860100079 | 102W-5 | 102W-5 | OSOM hCG Card 5 Test kit | SEKISUI DIAGNOSTICS, LLC | |
48 | 00742860100031 | 755425 | 755425 | HCG COMBO, MERIDIAN 25 test Kit | SEKISUI DIAGNOSTICS, LLC | |
49 | 00742860001246 | 124 | 124 | OSOM Combo hCG 25 Test kit | SEKISUI DIAGNOSTICS, LLC | |
50 | 00742860001024 | 102W | 102W | OSOM hCG Card 25 Test Kit | SEKISUI DIAGNOSTICS, LLC |