| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10859035006061 | 60C4 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ TEST KIT (5000 TESTS) | |||
| 2 | 10859035006252 | 61C6 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 15 WELL TEST CARDS 300 EA | |||
| 3 | 10859035006160 | 61C9 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ DISPENSING BOTTLES 10 EA | |||
| 4 | 10859035006078 | 60C6 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 30 WELL CARDS KIT (5000 TESTS) | |||
| 5 | 10859035006030 | 60C1 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ TEST KIT (50 TESTS) | |||
| 6 | 10859035006214 | 47050 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | Wampole ColorCard® ASO | |||
| 7 | 10859035006153 | 61C8 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ NEEDLE/SHEATH 10 EA | |||
| 8 | 10859035006092 | 61C1 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ ANTIGEN SUSPENSION 10 X 3ML | |||
| 9 | 10859035006122 | 61C4 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ PIPETS/STIRRERS 500 EA | |||
| 10 | 10859035006221 | 46050 | GTY | Antigens, All Groups, Streptococcus Spp. | Wampole ColorCard® Streptozyme® | |||
| 11 | 10859035006085 | 61C0 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ ANTIGEN SUSPENSION 3 X 3ML | |||
| 12 | 10859035006016 | 71S2 | DCN | System, Test, C-Reactive Protein | IMMUNEX CRP® | |||
| 13 | 10859035006115 | 61C3 | GMQ | Antigens, Nontreponemal, All | 2 | IMPACT RPR™ LIQUID CONTROL 3 X 1 ML | ||
| 14 | 10859035006245 | 84R2 | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | Alere Rubella-plus® | |||
| 15 | 10859035006184 | 62C5 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 10 WELL TEST CARDS 50 EA | |||
| 16 | 10859035006146 | 61C7 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 30 WELL TEST CARDS 100 EA | |||
| 17 | 10859035006238 | 92407 | KTN | System, Test, Infectious Mononucleosis | Acceava® Mono Cassette | |||
| 18 | 10859035006177 | 62C4 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ PIPETS/STIRRERS 250 EA | |||
| 19 | 10859035006207 | 36045 | DHR | System, Test, Rheumatoid Factor | Wampole Colorcard® RF | |||
| 20 | 10859035006191 | 27135 | KTN | System, Test, Infectious Mononucleosis | Wampole ColorCard® Mono | |||
| 21 | 10859035006108 | 61C2 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ DRY CONTROL CARDS 10 EA | |||
| 22 | 10859035006054 | 60C3 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ TEST KIT (500 TESTS) | |||
| 23 | 10859035006047 | 60C2 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ TEST KIT (150 TESTS) | |||
| 24 | 10859035006139 | 61C5 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 10 WELL TEST CARDS 300 EA | |||
| 25 | 10859035006009 | 34S2 | DHR | System, Test, Rheumatoid Factor | RHEUMATEX® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00860146001527 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
| 2 | 00860146001510 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
| 3 | 00860146001503 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
| 4 | 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. |
| 5 | 00857338006323 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE® | HEMOSURE INC. |
| 6 | 00857338006316 | T1-CM50 | T1-CM50 | Hemosure iFOB 50 Mailers Only Box Set | HEMOSURE® | HEMOSURE INC. |
| 7 | 00857338006309 | T1-CK30 | T1-CK30 | Hemosure iFOB Test 30 Cassettes and 50 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
| 8 | 00857338006194 | T1-TB10 | T1-TB10 | Hemosure iFOB Buffer Tube Box Set (10 Purple Cap Tubes with Short Labels) | HEMOSURE® | HEMOSURE INC. |
| 9 | 00857338006132 | T1-CM50 | T1-CM50 | Hemosure FOB 50 Mailers Only Box Set | HEMOSURE | HEMOSURE INC. |
| 10 | 00857338006125 | DUO-CM10 | DUO-CM10 | Hemosure iFOB Prepacked 10 Mailers Box Set with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
| 11 | 00857338006118 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE | HEMOSURE INC. |
| 12 | 00857338006101 | Prepack-CM25 | Prepack-CM25 | Individual Prepacked Mailer with One Tube in Each Mailer; Packed in a Plastic Bag | HEMOSURE® | HEMOSURE INC. |
| 13 | 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. |
| 14 | 00857338006088 | T1-CK30T | T1-CK30T | Hemosure iFOB Test 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
| 15 | 00857338006071 | T1-CT30 | T1-CT30 | Hemosure iFOB Test 30 Cassettes Box Set | HEMOSURE® | HEMOSURE INC. |
| 16 | 00857338006064 | T1-CT50 | T1-CT50 | Hemosure FOB Test 50 Cassettes Box Set | HEMOSURE® | HEMOSURE INC. |
| 17 | 00857338006057 | T1-CK50 | T1-CK50 | Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
| 18 | 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. |
| 19 | 00857338006033 | T1-CK25 | T1-CK25 | Hemosure iFOB Test 25 Cassettes and 25 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
| 20 | 00857338006026 | T1-CK10 | T1-CK10 | Hemosure iFOB Test 10 Cassettes and 10 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
| 21 | 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. |
| 22 | 00855574005346 | FBPUS | Personal Use Kit OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 23 | 00855574005339 | FBT-StarterS | Starter Pack OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 24 | 00855574005322 | FOB50S | Test Kit OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 25 | 00855574005315 | FOBBTLS | Sampling Bottles OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 26 | 00855574005308 | FOBSTRS | OC-Light S Test Strips | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 27 | 00855574005193 | FBPU-BULKS | Personal Use Kit Bulk, OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 28 | 00855574005094 | FOBSTR | OC-Light Test Strips | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 29 | 00855574005070 | FOBBTL | Sampling Bottles OC-Light | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 30 | 00855574005063 | FOB50 | OC-Light Test Kit | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 31 | 00855574005056 | FBT-Starter | Starter Pack OC-Light | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 32 | 00853691007595 | 1 | FOB Rapid Test Cassette | FOB Rapid Test Cassette | ACRO BIOTECH INC | |
| 33 | 00850093003354 | 01 | 90035.01 | InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
| 34 | 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. | |
| 35 | 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. | |
| 36 | 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. |
| 37 | 00850093003293 | 01 | 14103.01 | InSure® ONE™ Run Buffer - 1 Liter Bottle | InSure® ONE™ | ENTERIX INC. |
| 38 | 00850093003286 | 01 | 11018.01 | InSure® ONE™ Test Cards for QC - 50 pack | InSure® ONE™ | ENTERIX INC. |
| 39 | 00850093003279 | 01 | 90030.01 | InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
| 40 | 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. |
| 41 | 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. |
| 42 | 00850093003095 | 01 | 14103 | InSure FIT Run Buffer - 1 Liter Bottle | InSure FIT | ENTERIX INC. |
| 43 | 00850093003088 | 01 | InSure FIT Test Strip | InSure FIT | ENTERIX INC. | |
| 44 | 00850093003071 | 01 | 11018 | InSure FIT Test Cards for QC - 50 pack | InSure FIT | ENTERIX INC. |
| 45 | 00850093003064 | 01 | 15022 | InSure FIT Kit | InSure FIT | ENTERIX INC. |
| 46 | 00850093003040 | 01 | InSure FIT Combo Pack | InSure FIT | ENTERIX INC. | |
| 47 | 00850093003019 | 01 | 80025 | InSure FIT Developer Kit | InSure FIT | ENTERIX INC. |
| 48 | 00850011007167 | TNR IFOB36 | TNR IFOB36 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |
| 49 | 00850011007150 | TNR IFOB | TNR IFOB | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 20/BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |
| 50 | 00818566016430 | 6923 | Seracult Plus Fecal Occult Blood Test, Developer | PremierPro | SVS LLC |