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 | 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 |
48 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
49 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
50 | 30014613201250 | 20125 | 20125 | QkVue Strep A Dpstk 25T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00748349000083 | 10210 | ForSure iFOB reagent buffer only (no test cassette) | ForSure iFOB Test (buffer only) | SYNTRON BIORESEARCH, INC. | |
2 | 00748349000076 | 10210 | ForSure iFOB test cassette only (no buffer) | ForSure iFOB Test (cassette only) | SYNTRON BIORESEARCH, INC. | |
3 | 00748349000021 | 10210 | ForSure iFOB test setContains:1 test device1 test reagent buffer1 sample collect ForSure iFOB test setContains:1 test device1 test reagent buffer1 sample collection set (may or may not be included) | ForSure iFOB Test Set | SYNTRON BIORESEARCH, INC. | |
4 | 00742860100321 | 1001 | 1001 | OSOM iFOBT Stool Collection Tube | SEKISUI DIAGNOSTICS, LLC | |
5 | 00742860100192 | 1002 | 1002 | OSOM iFOB 25T Kit | OSOM iFOB 25T Kit | SEKISUI DIAGNOSTICS, LLC |
6 | 00722066004999 | FOB-0MBC | Rapid Response FIT Mailers&Buffers&Cassettes - 36 Mailers + Buffers + Cassettes/Box | Rapid Response | BTNX INC | |
7 | 00722066004746 | FOB-9V30 | Rapid Response FIT Test Buffer | Rapid Response | BTNX INC | |
8 | 00722066001882 | FOB-9C36 | FOB-9C36 | Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection of human hemoglobin in feces. | Rapid Response | BTNX INC |
9 | 00695684742522 | 74252 | Triple slide patient take home version of a rapid test for the qualitative detec Triple slide patient take home version of a rapid test for the qualitative detection of occult blood in stool specimens. Full Compliance features include Pre-Paid postage return envelops, compliance monitoring reminders, return labels. | COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 50 TRI-SLIDES | GERMAINE LABORATORIES, INC | |
10 | 00695684742508 | 74250 | Triple slide patient take home version of a rapid test for the qualitative detec Triple slide patient take home version of a rapid test for the qualitative detection of occult blood in stool specimens. | COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 50 TRI-SLIDES | GERMAINE LABORATORIES, INC | |
11 | 00695684742119 | 74211 | IFOB Controls | IFOB CONTROLS | GERMAINE LABORATORIES, INC | |
12 | 00695684742089 | 74208 | Developer solution for use with Compliance Gold FOB tests. | COMPLIANCE GOLD FOB DEVELOPER 8x10mL | GERMAINE LABORATORIES, INC | |
13 | 00695684742003 | 74200 | Fecal occult blood rapid assay for the qualitative detection of occult blood in Fecal occult blood rapid assay for the qualitative detection of occult blood in human stool samples. | COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 100 SINGLE SLIDES | GERMAINE LABORATORIES, INC | |
14 | 00695684741334 | 74133 | AIMSTEP iFOB EASY | GERMAINE LABORATORIES, INC | ||
15 | 00695684740344 | 74034 | Immunological fecal occult blood rapid assay for the qualitative detection of fe Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples. Full Compliance. | COMPLIANCE GOLD iFOB FC | GERMAINE LABORATORIES, INC | |
16 | 00695684740337 | 74033 | Immunological fecal occult blood rapid assay for the qualitative detection of fe Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples. | COMPLIANCE GOLD iFOB EASY | GERMAINE LABORATORIES, INC | |
17 | 00695684740306 | 74030 | Immunological fecal occult blood rapid assay for the qualitative detection of fe Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples. | COMPLIANCE GOLD iFOB SIMPLE | GERMAINE LABORATORIES, INC | |
18 | 00695684740153 | 74015 | Patient collection kits for IFOB kit | COMPLIANCE GOLD iFOB PATIENT COLLECTION KITS | GERMAINE LABORATORIES, INC | |
19 | 00695684740146 | 74014 | Patient collection kits for IFOB kit, for Full Compliance version | COMPLIANCE GOLD iFOB PATIENT COLLECTION KITS FC | GERMAINE LABORATORIES, INC | |
20 | 00695684740085 | 74008 | IFOB Collection Bottles, to be used with IFOB kit | IFOB COLLECTION BOTTLES | GERMAINE LABORATORIES, INC | |
21 | 00693501000220 | HP | HemaPrompt fecal occult blood test | HemaPrompt | AERSCHER, INC | |
22 | 00693501000152 | HPFG | HemaPrompt FG Fecal and Gastric Test Kit | HemaPrompt FG | AERSCHER, INC | |
23 | 00691573700154 | 700-C | 700-C-1 | Positive control for guaiac based fecal occult blood slide tests | Camco | CAMBRIDGE DIAGNOSTIC PRODUCTS INC |
24 | 00657498129012 | 1290-100 | 1290-100 | Hema-Screen is a guaiac slide test for the qualitative detection of fecal occult blood. | Hema-Screen Lab Pack | STANBIO LABORATORY, L.P. |
25 | 00630414538396 | 10313614 | 2596 | For use with the in vitro diagnostic Hema-Chek® Slide Test for the Qualitatitive For use with the in vitro diagnostic Hema-Chek® Slide Test for the Qualitatitive Determination of Fecal Occult Blood. | Hema-Chek® Developer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
26 | 00630414538389 | 10313436 | 2592 | Slide based In vitro diagnostics reagent tests for the Qualitative Determination Slide based In vitro diagnostics reagent tests for the Qualitative Determination of Fecal Occult Blood. | Hema-Chek® Slide Test | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
27 | 00613647100035 | 23038039 | Fisher FOBT Tape | FISHER SCIENTIFIC COMPANY L.L.C. | ||
28 | 00613647001066 | 551790 | Fisher Labcorp ES Take Home Pack 80 | FISHER SCIENTIFIC COMPANY L.L.C. | ||
29 | 00613647001059 | 551984 | Fisher Labcorp ES Lab Pack 100 Count | FISHER SCIENTIFIC COMPANY L.L.C. | ||
30 | 00613647001042 | 551985 | Fisher Labcorp ES 1000 Singles Pack | FISHER SCIENTIFIC COMPANY L.L.C. | ||
31 | 00613647000700 | 23038036 | SURE-VUE FOBT ES TRIPLE 80/PK | FISHER SCIENTIFIC COMPANY L.L.C. | ||
32 | 00613647000694 | 23038035 | SURE-VUE FOBT ES SINGLE 100/PK | FISHER SCIENTIFIC COMPANY L.L.C. | ||
33 | 00613647000687 | 23038040 | SURE-VUE FOBT BULK PK 1000/PK | FISHER SCIENTIFIC COMPANY L.L.C. | ||
34 | 00613647000670 | 23038031 | SURE-VUE FOBT 100/PK | FISHER SCIENTIFIC COMPANY L.L.C. | ||
35 | 00613647000663 | 23038032 | SURE-VUE FOBT TRIPLES 80/PK | FISHER SCIENTIFIC COMPANY L.L.C. | ||
36 | 00613647000656 | 23038033 | DEVELOPER 15ML 20/PK | FISHER SCIENTIFIC COMPANY L.L.C. | ||
37 | 00613647000649 | 23038037 | SURE-VUE FOBT ES DEV15ML 20/PK | FISHER SCIENTIFIC COMPANY L.L.C. | ||
38 | 00613647000632 | 23038041 | SURE-VUE FOBT ES BULK 1000/PK | FISHER SCIENTIFIC COMPANY L.L.C. | ||
39 | 00304040054185 | 5700610 | 5700610 | OC-Light S Test Strips | Henry Schein | HENRY SCHEIN, INC. |
40 | 00304040016763 | 1127142 | 1127142 | OneStep+ ER Developer | Henry Schein | HENRY SCHEIN, INC. |
41 | 00304040016756 | 1471963 | 1471963 | One Step Occult Developer | Henry Schein | HENRY SCHEIN, INC. |
42 | 00304040002599 | 1127141 | 1127141 | One Step ER Mailer | Henry Schein | HENRY SCHEIN, INC. |
43 | 00304040002582 | 1127140 | 1127140 | One Step ER Slide | Henry Schein | HENRY SCHEIN, INC. |
44 | 00304040002568 | 9004416 | 9004416 | One Step iFOBT Return Mailers | Henry Schein | HENRY SCHEIN, INC. |
45 | 00304040002551 | 9007458 | 9007458 | OneStep+ IFOB Test Cassette | Henry Schein | HENRY SCHEIN, INC. |
46 | 00304040002544 | 9004413 | 9004413 | One Step iFOBT Tests w/Mailers | Henry Schein | HENRY SCHEIN, INC. |
47 | 00304040002537 | 1477182 | 1477182 | One Step Occult Blood Mailer | Henry Schein | HENRY SCHEIN, INC. |
48 | 00304040002520 | 1471246 | 1471246 | One Step Fecal Occult Slide | Henry Schein | HENRY SCHEIN, INC. |
49 | 00083059100013 | 1000-1 | Home Test For Hidden Blood in The Stool | EZ Detect Colon Disease Test | BIOMERICA, INC. | |
50 | 00083059010015 | 1001 | The EZ DETECT Test is for in vitro qualitative detection of occult blood in the The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use. | EZ Detect Fecal Occult Blood Test | BIOMERICA, INC. |