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 | 04015630946426 | 7790228001 | 7790228001 | Urisys 1100 Urine Analyzer | ROCHE DIAGNOSTICS GMBH | |
2 | 00893230002032 | KT-313 | KT-313 | Fecal Occult Blood Test | EDI™ CARE™ | EPITOPE DIAGNOSTICS INC |
3 | 00860146001527 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
4 | 00860146001510 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
5 | 00860146001503 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
6 | 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. |
7 | 00857338006323 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE® | HEMOSURE INC. |
8 | 00857338006316 | T1-CM50 | T1-CM50 | Hemosure iFOB 50 Mailers Only Box Set | HEMOSURE® | HEMOSURE INC. |
9 | 00857338006309 | T1-CK30 | T1-CK30 | Hemosure iFOB Test 30 Cassettes and 50 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
10 | 00857338006194 | T1-TB10 | T1-TB10 | Hemosure iFOB Buffer Tube Box Set (10 Purple Cap Tubes with Short Labels) | HEMOSURE® | HEMOSURE INC. |
11 | 00857338006132 | T1-CM50 | T1-CM50 | Hemosure FOB 50 Mailers Only Box Set | HEMOSURE | HEMOSURE INC. |
12 | 00857338006125 | DUO-CM10 | DUO-CM10 | Hemosure iFOB Prepacked 10 Mailers Box Set with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
13 | 00857338006118 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE | HEMOSURE INC. |
14 | 00857338006101 | Prepack-CM25 | Prepack-CM25 | Individual Prepacked Mailer with One Tube in Each Mailer; Packed in a Plastic Bag | HEMOSURE® | HEMOSURE INC. |
15 | 00857338006095 | DUO-iFOB20 | DUO-iFOB20 | Hemosure iFOB Prepacked DUO-iFOB Test 20 Cassettes and 10 Mailers Box Kit with T Hemosure iFOB Prepacked DUO-iFOB Test 20 Cassettes and 10 Mailers Box Kit with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
16 | 00857338006088 | T1-CK30T | T1-CK30T | Hemosure iFOB Test 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
17 | 00857338006071 | T1-CT30 | T1-CT30 | Hemosure iFOB Test 30 Cassettes Box Set | HEMOSURE® | HEMOSURE INC. |
18 | 00857338006064 | T1-CT50 | T1-CT50 | Hemosure FOB Test 50 Cassettes Box Set | HEMOSURE® | HEMOSURE INC. |
19 | 00857338006057 | T1-CK50 | T1-CK50 | Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
20 | 00857338006040 | PRE-PACK iFOB20 | PRE-PACK iFOB20 | Hemosure iFOB Prepacked iFOB Test 20 Cassettes and 20 Mailers Box Kit with One B Hemosure iFOB Prepacked iFOB Test 20 Cassettes and 20 Mailers Box Kit with One Buffer Tube in Each Mailer | HEMOSURE® | HEMOSURE INC. |
21 | 00857338006033 | T1-CK25 | T1-CK25 | Hemosure iFOB Test 25 Cassettes and 25 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
22 | 00857338006026 | T1-CK10 | T1-CK10 | Hemosure iFOB Test 10 Cassettes and 10 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
23 | 00857338006019 | T1-CK30 | T1-CK30 | contains T1-CT30, T1-TB50, T1-CM50. T1-CT30: Hemosure iFOB Test 30 Cassettes Box contains T1-CT30, T1-TB50, T1-CM50. T1-CT30: Hemosure iFOB Test 30 Cassettes Box SetT1-TB50: Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels)T1-CM50: Hemosure iFOB 50 Mailers Only Box Set | Hemosure | HEMOSURE INC. |
24 | 00855574005346 | FBPUS | Personal Use Kit OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
25 | 00855574005339 | FBT-StarterS | Starter Pack OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
26 | 00855574005322 | FOB50S | Test Kit OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
27 | 00855574005315 | FOBBTLS | Sampling Bottles OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
28 | 00855574005308 | FOBSTRS | OC-Light S Test Strips | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
29 | 00855574005193 | FBPU-BULKS | Personal Use Kit Bulk, OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
30 | 00855574005094 | FOBSTR | OC-Light Test Strips | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
31 | 00855574005070 | FOBBTL | Sampling Bottles OC-Light | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
32 | 00855574005063 | FOB50 | OC-Light Test Kit | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
33 | 00855574005056 | FBT-Starter | Starter Pack OC-Light | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
34 | 00853691007595 | 1 | FOB Rapid Test Cassette | FOB Rapid Test Cassette | ACRO BIOTECH INC | |
35 | 00850093003354 | 01 | 90035.01 | InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
36 | 00850093003323 | 01 | InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bulk pouch of 200 Strips (Part Number 12041.01) | InSure® ONE™ | ENTERIX INC. | |
37 | 00850093003316 | 01 | InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027 InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01, and 90010.01), 25-packs (Part Number 90025.01) and 50-packs (15030.01, 15040.01, and 90050.01) | InSure® ONE™ | ENTERIX INC. | |
38 | 00850093003309 | 01 | 90002.01 | InSure® ONE™ Sample Kit - NOT FOR SALEContains 2 Collection Kits, 2 individually InSure® ONE™ Sample Kit - NOT FOR SALEContains 2 Collection Kits, 2 individually-pouched Test Strips, and 1 bottle of Run Buffer (9mL) | InSure® ONE™ | ENTERIX INC. |
39 | 00850093003293 | 01 | 14103.01 | InSure® ONE™ Run Buffer - 1 Liter Bottle | InSure® ONE™ | ENTERIX INC. |
40 | 00850093003286 | 01 | 11018.01 | InSure® ONE™ Test Cards for QC - 50 pack | InSure® ONE™ | ENTERIX INC. |
41 | 00850093003279 | 01 | 90030.01 | InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
42 | 00850093003231 | 01 | 80025.01 | InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 bottle of Run Buffer (9mL) | InSure® ONE™ | ENTERIX INC. |
43 | 00850093003187 | 01 | 90002 | InSure FIT Sample Kit - NOT FOR SALEContains 2 Patient Collection Kits, 2 Test S InSure FIT Sample Kit - NOT FOR SALEContains 2 Patient Collection Kits, 2 Test Strips, and 1 Run Buffer Bottle | InSure FIT | ENTERIX INC. |
44 | 00850093003095 | 01 | 14103 | InSure FIT Run Buffer - 1 Liter Bottle | InSure FIT | ENTERIX INC. |
45 | 00850093003088 | 01 | InSure FIT Test Strip | InSure FIT | ENTERIX INC. | |
46 | 00850093003071 | 01 | 11018 | InSure FIT Test Cards for QC - 50 pack | InSure FIT | ENTERIX INC. |
47 | 00850093003064 | 01 | 15022 | InSure FIT Kit | InSure FIT | ENTERIX INC. |
48 | 00850093003040 | 01 | InSure FIT Combo Pack | InSure FIT | ENTERIX INC. | |
49 | 00850093003019 | 01 | 80025 | InSure FIT Developer Kit | InSure FIT | ENTERIX INC. |
50 | 00850011007167 | TNR IFOB36 | TNR IFOB36 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |