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 | 30014613201977 | 20197 | 20197 | QkVue iFOB Control Set | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
45 | 30014613201960 | iFOB Test | 20196 | QuickVue iFOB Collect Kit 10T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
46 | 30014613201946 | iFOB Test | 20194 | QuickVue iFOB 20T | 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 | 10613647001445 | 23048004 | 23048004 | Sure-Vue Signature iFOBT 50 collection tubes only | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
2 | 10613647001438 | 23048003 | 23048003 | Sure-Vue Signature iFOBT 50 test cassettes only | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
3 | 10613647001421 | 23048002 | 23048002 | Sure-Vue Signature iFOBT 50 test kit with 50 tubes | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
4 | 10613647001414 | 23048001 | 23048001 | Sure-Vue Signature iFOBT 30 test kit with 30 tubes | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
5 | 10613647001407 | 23048000 | 23048000 | Sure-Vue Signature iFOBT 30 test kit with 50 tubes and 50 mailers | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
6 | 10612479198828 | 551748 | DEVELOPER, OCCULT BLD SOL 15ML | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
7 | 10612479198811 | 301 | DEVELOPER, OCCULT BLD SOL 15ML | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
8 | 10304040102524 | 5701171 | 5701171 | Positive/Negative Controls for OC-Light and OC-Light S | Henry Schein | HENRY SCHEIN, INC. |
9 | 10304040102517 | 5701172 | 5701172 | Sampling Bottles OC-Light S | Henry Schein | HENRY SCHEIN, INC. |
10 | 10304040054175 | 5700609 | 5700609 | Test Kit OC-Light S | Henry Schein | HENRY SCHEIN, INC. |
11 | 10304040054168 | 5700607 | 5700607 | OC Light S FIT Personal Use Kit | Henry Schein | HENRY SCHEIN, INC. |
12 | M52556560 | 5656 | ColoCARE Hospital Pack | HELENA LABORATORIES CORPORATION | ||
13 | M52556510 | 5651 | ColoCARE Office Pack | HELENA LABORATORIES CORPORATION | ||
14 | M52556500 | 5650 | ColoCARE Screening Pack | HELENA LABORATORIES CORPORATION | ||
15 | M5255521380 | 552138 | ColoCare - 9 Health Fair | HELENA LABORATORIES CORPORATION | ||
16 | M5255520520 | 552052 | ColoScreen Triples 1000 Pack w/o Developer | HELENA LABORATORIES CORPORATION | ||
17 | M5255515650 | 551565 | ColoScreen | HELENA LABORATORIES CORPORATION | ||
18 | M5255515470 | 551547 | ColoCare - NR | HELENA LABORATORIES CORPORATION | ||
19 | M52550880 | 5088 | ColoScreen-ES Developer-15 | HELENA LABORATORIES CORPORATION | ||
20 | M52550860 | 5086 | ColoScreen-ES Lab Pack | HELENA LABORATORIES CORPORATION | ||
21 | M52550850 | 5085 | ColoScreen-ES Take Home Pack | HELENA LABORATORIES CORPORATION | ||
22 | M52550830 | 5083 | ColoScreen III 1000 Slide Pack | HELENA LABORATORIES CORPORATION | ||
23 | M52550820 | 5082 | ColoScreen III Lab Pack | HELENA LABORATORIES CORPORATION | ||
24 | M52550790 | 5079 | ColoScreen Tape | HELENA LABORATORIES CORPORATION | ||
25 | M52550780 | 5078 | ColoScreen Developer 2 | HELENA LABORATORIES CORPORATION | ||
26 | M52550760 | 5076 | ColoScreen 1000 Slide Pack | HELENA LABORATORIES CORPORATION | ||
27 | M52550730 | 5073 | ColoScreen III Take Home Pack | HELENA LABORATORIES CORPORATION | ||
28 | M52550720 | 5072 | ColoScreen Lab Pack | HELENA LABORATORIES CORPORATION | ||
29 | M52550710 | 5071 | ColoScreen III Office Pack | HELENA LABORATORIES CORPORATION | ||
30 | M52550640 | 5064 | ColoScreen iFOBT Office Kit | HELENA LABORATORIES CORPORATION | ||
31 | M52550631 | 5063 | ColoScreen iFOBT Mailer | HELENA LABORATORIES CORPORATION | ||
32 | M52550621 | 5062 | ColoScreen iFOBT Cassettes | HELENA LABORATORIES CORPORATION | ||
33 | M52550611 | 5061 | ColoScreen iFOBT Collection Tubes | HELENA LABORATORIES CORPORATION | ||
34 | M5255000910 | 500091 | ColoScreen Developer | HELENA LABORATORIES CORPORATION | ||
35 | M52510020 | 1002 | ColoScreen III Mailing Envelopes | HELENA LABORATORIES CORPORATION | ||
36 | 08806125630229 | IM706-100M | The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an imm The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. | OcculTech Fecal Occult Blood Rapid Test | YD DIAGNOSTICS CORP. | |
37 | M220P088283 | P080028 | P080028 | Pro Advantage FOB Developer Solutions 8X10ML 8/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
38 | M220P0800183 | P080018 | P080018 | Pro Advantage FOB Lab Pack 100/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
39 | 08305900100013 | 1000-1 | Home Test For Hidden Blood in The Stool | EZ Detect Colon Disease Test | BIOMERICA, INC. | |
40 | 08305900010015 | 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. | |
41 | 06970277512473 | TFO-602 | TFO-602 | FOB Rapid Test Cassette Box of 25 kits. | FOB Rapid Test Cassette | HANGZHOU ALLTEST BIOTECH CO., LTD. |
42 | 04015630946426 | 7790228001 | 7790228001 | Urisys 1100 Urine Analyzer | ROCHE DIAGNOSTICS GMBH | |
43 | 00893230002032 | KT-313 | KT-313 | Fecal Occult Blood Test | EDI™ CARE™ | EPITOPE DIAGNOSTICS INC |
44 | 00860146001527 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
45 | 00860146001510 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
46 | 00860146001503 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
47 | 00857338006934 | T1-CK50MUS | T1-CK50MUS | Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers (Made in USA) | HEMOSURE® | HEMOSURE INC. |
48 | 00857338006323 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE® | HEMOSURE INC. |
49 | 00857338006316 | T1-CM50 | T1-CM50 | Hemosure iFOB 50 Mailers Only Box Set | HEMOSURE® | HEMOSURE INC. |
50 | 00857338006309 | T1-CK30 | T1-CK30 | Hemosure iFOB Test 30 Cassettes and 50 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |