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 | 30014613202011 | iFOB Test | 20201 | QuickVue iFOB Tray Pack 50T | 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 | 00850093003354 | 01 | 90035.01 | InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
2 | 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. | |
3 | 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. | |
4 | 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. |
5 | 00850093003293 | 01 | 14103.01 | InSure® ONE™ Run Buffer - 1 Liter Bottle | InSure® ONE™ | ENTERIX INC. |
6 | 00850093003286 | 01 | 11018.01 | InSure® ONE™ Test Cards for QC - 50 pack | InSure® ONE™ | ENTERIX INC. |
7 | 00850093003279 | 01 | 90030.01 | InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
8 | 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. |
9 | 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. |
10 | 00850093003095 | 01 | 14103 | InSure FIT Run Buffer - 1 Liter Bottle | InSure FIT | ENTERIX INC. |
11 | 00850093003088 | 01 | InSure FIT Test Strip | InSure FIT | ENTERIX INC. | |
12 | 00850093003071 | 01 | 11018 | InSure FIT Test Cards for QC - 50 pack | InSure FIT | ENTERIX INC. |
13 | 00850093003064 | 01 | 15022 | InSure FIT Kit | InSure FIT | ENTERIX INC. |
14 | 00850093003040 | 01 | InSure FIT Combo Pack | InSure FIT | ENTERIX INC. | |
15 | 00850093003019 | 01 | 80025 | InSure FIT Developer Kit | InSure FIT | ENTERIX INC. |
16 | 00850011007167 | TNR IFOB36 | TNR IFOB36 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |
17 | 00850011007150 | TNR IFOB | TNR IFOB | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 20/BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |
18 | 00818566016430 | 6923 | Seracult Plus Fecal Occult Blood Test, Developer | PremierPro | SVS LLC | |
19 | 00818566016423 | 6920 | Seracult Plus Fecal Occult Blood Test, Single Slide | PremierPro | SVS LLC | |
20 | 00818566016416 | 6916 | Seracult Fecal Occult Blood Test, Developer | PremierPro | SVS LLC | |
21 | 00818566016409 | 6915 | Seracult Fecal Occult Blood Test, Triple Slide | PremierPro | SVS LLC | |
22 | 00818566016393 | 6914 | Seracult Fecal Occult Blood Test, Tape and Developer Kit | PremierPro | SVS LLC | |
23 | 00818566016386 | 6910 | Seracult Fecal Occult Blood Test, Single Slide | PremierPro | SVS LLC | |
24 | 00818566016379 | 6922 | Seracult Plus Fecal Occult Blood Test, Triple Slide Mailing Kit | PremierPro | SVS LLC | |
25 | 00818566016362 | 6921 | Seracult Plus Fecal Occult Blood Test, Single Slide | PremierPro | SVS LLC | |
26 | 00818566016355 | 6913 | Seracult Fecal Occult Blood Test, Triple Slide Mailing Kit | PremierPro | SVS LLC | |
27 | 00818566016348 | 6912 | Seracult Fecal Occult Blood Test, Triple Slide Patient Kit | PremierPro | SVS LLC | |
28 | 00818566016331 | 6911 | Seracult Fecal Occult Blood Test, Single Slide | PremierPro | SVS LLC | |
29 | 00817763021841 | T1-TB100L | T1-TB100L | Hemosure FOB Buffer Tube Plain Box Set (100 Purple Cap Tubes with Long Labels) | HEMOSURE® | HEMOSURE INC. |
30 | 00817763021797 | T1-CK50US | T1-CK50US | Hemosure FOB Test 50 Cassettes and 50 Collection Tubes per Box Kit without Maile Hemosure FOB Test 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer (Made in USA) | HEMOSURE® | HEMOSURE INC. |
31 | 00817763020134 | CM5-IUH | CM5-IUH | IU Health Pathology Laboratory Mailers Contains Patient Instruction and Buffer T IU Health Pathology Laboratory Mailers Contains Patient Instruction and Buffer Tube; 100 Mailers/Box | HEMOSURE® | HEMOSURE INC. |
32 | 00816917025728 | FBPUS-UH | Personal Use Kit OC-Light S, for Union Hospital | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
33 | 00816917025704 | FBPUS-MBAP | Personal Use Kit OC-Light S, for Missouri Baptist Med Ctr | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
34 | 00816917025681 | FBPUS-EHICH | Personal Use Kit OC-Light S, for Emanate Health Inter-Comm Hospital | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
35 | 00816917025582 | FBPUS-GOSH | Personal Use Kit OC-Light S, for Goshen Health | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
36 | 00816917025506 | FBPUS-MONH | Personal Use Kit OC-Light S, for Monument Health | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
37 | 00816917025223 | FBPUS-LHCH | Personal Use Kit OC-Light S, for Lebauer Healthcare Cone Health | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
38 | 00816917025087 | FBPUS-AL | Personal Use Kit OC-Light S, for Alverno Labs | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
39 | 00816917025063 | FBPUS-VFC | Personal Use Kit OC-Light S, for Venice Family Clinic | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
40 | 00816917025056 | FBPUS-OMC | Personal Use Kit OC-Light S, for Olympic Medical Center | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
41 | 00816917025001 | FBPUS-LCPSC | Personal Use Kit OC-Light S, Custom Kit for Lexington Clinic, PSC | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
42 | 00816917024820 | FBPUS-AAPH | Personal Use Kit OC-Light S, Custom Kit for Albany Area Primary Healthcare, Inc. | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
43 | 00816917024813 | FBPUS-SCHS | Personal Use Kit OC-Light S, Custom Kit for St. Charles Health System | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
44 | 00816917024806 | FBPUS-GRPH | Personal Use Kit OC-Light S, Custom Kit for Guthrie Robert Packer Hospital | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
45 | 00816917024790 | FBPUS-CHA CPCC | Personal Use Kit OC-Light S, Custom Kit for (CHA) Cambridge Primary Care Center | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
46 | 00816917024783 | FBPUS-CMH MRHC | Personal Use Kit OC-Light S, Custom Kit for Comm Mem Hosp/Moorland Reserve Healt Personal Use Kit OC-Light S, Custom Kit for Comm Mem Hosp/Moorland Reserve Health Center (Froedert) | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
47 | 00816917024592 | FBPUS-BMHL | Personal Use Kit OC-Light S, Custom Kit for Bronson Methodist Hospital Laboratory | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
48 | 00816917024578 | FBPUS-MWH | Personal Use Kit OC-Light S, Custom Kit for Melrose Wakefield Hosp | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
49 | 00816917024561 | FBPUS-CHWC | Personal Use Kit OC-Light S, Custom Kit for Community Hospitals & Wellness Cente Personal Use Kit OC-Light S, Custom Kit for Community Hospitals & Wellness Centers - Cardinal | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
50 | 00816917024554 | FBPUS-CMH FHMG | Personal Use Kit OC-Light S, Custom Kit for Froedtert Health Medical Group | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC |