No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M52592330 | 9233 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Antiserum to Human Serum | ||
2 | M52590150 | 9015 | JZR | SUPPORT GELS | 1 | IEP Sponge Wicks (2/pkg) | ||
3 | M52558520 | 5852 | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | Plateletworks Combo-25 Kit | ||
4 | M5255526140 | 552614 | JHO | ELECTROPHORETIC SEPARATION, LIPOPROTEINS | 1 | SPIFE Vis Cholesterol Kit | ||
5 | M5255527030 | 552703 | CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | SPIFE Nexus IFE-6 Antisera Kit | ||
6 | M525AQCHP0 | AQC-HP | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Actalyke QC Kit - AQC-HP | ||
7 | M52552920 | 5292 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Protein S ELISA Kit | ||
8 | M52551280 | 5128 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
9 | M52590140 | 9014 | JJN | APPARATUS, ELECTROPHORESIS, FOR CLINICAL USE | 1 | Zip Zone Sponge Wicks | ||
10 | M5258JF520010 | 8JF52001 | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | AggRAM Module (Domestic) | ||
11 | M52563000000 | 6300000 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Pipette, Variable Volume, 10-100 microliter | ||
12 | M52557700040 | 5770004 | JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME | 2 | Actalyke XL, (CSA/CE), W/ Flash Memory | ||
13 | M52556510 | 5651 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoCARE Office Pack | ||
14 | M52518200 | 1820 | CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | V8 WASTE DRAWER PACK | ||
15 | M52592500 | 9250 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Antiserum to Human IgE | ||
16 | M5255526040 | 552604 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | SPIFE Alkaline Phosphatase Gel Kit | ||
17 | M5255525970 | 552597 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Blade Applicator Kit, 12 Sample | ||
18 | M5255524710 | 552471 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | SPIFE SPE HI RES 20 KIT | ||
19 | M5255524570 | 552457 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE IgG IEF-10 Kit | ||
20 | M5255523040 | 552304 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | QUICKGEL SPE Gel Kit | ||
21 | M5255522890 | 552289 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE ULTRA IFE-6 ANTISERA KIT | ||
22 | M5255521640 | 552164 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE Ultra ImmunoFix-9 Antisera Kit | ||
23 | M5255521360 | 552136 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS | ||
24 | M5255521250 | 552125 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE Ultra ImmunoFix-15 Antisera Kit | ||
25 | M5255519410 | 551941 | JHO | ELECTROPHORETIC SEPARATION, LIPOPROTEINS | 1 | SPIFE Vis Cholesterol Reagent Kit | ||
26 | M52553680 | 5368 | GHR | REAGENT, PLATELET AGGREGATION | 2 | Collagen Reagent | ||
27 | M52553600 | 5360 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Rocket Stain | ||
28 | M52553410 | 5341 | JPD | HEMOGLOBIN A2 QUANTITATION | 2 | Beta-Thal HbA2 Quik Column Kit | ||
29 | M52553390 | 5339 | JCM | CONTROL, HEMOGLOBIN, ABNORMAL | 2 | Normal HbA2 Quik Column Control | ||
30 | M52551340 | 5134 | JJT | ENZYME CONTROLS (ASSAYED AND UNASSAYED) | 1 | CK/LD Isoenzyme Control (5 x 2 mL) | ||
31 | M52551270 | 5127 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
32 | M52551250 | 5125 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
33 | M52551020 | 5102 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | Alkaline Phosphatase Indolyl Blue Reagent Kit | ||
34 | M52550930 | 5093 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Bufferizer | ||
35 | M52550900 | 5090 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Zip Zone Prep (1 x 60 mL) | ||
36 | M52550850 | 5085 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen-ES Take Home Pack | ||
37 | M52550830 | 5083 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen III 1000 Slide Pack | ||
38 | M52550820 | 5082 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen III Lab Pack | ||
39 | M52550050 | 5005 | KEM | AGENT, CLEARING | 1 | Clear Aid | ||
40 | M5255000910 | 500091 | KHE | REAGENT, OCCULT BLOOD | ColoScreen Developer | |||
41 | M52540840 | 4084 | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | Super Z Applicator (8-sample) | ||
42 | M52536150 | 3615 | GJG | Pipette, Quantitative, Hematology | 1 | H-Pette II (No Blade, Metal Canula) (1000 pieces) | ||
43 | M52536120 | 3612 | GJG | Pipette, Quantitative, Hematology | 1 | H-Pette with Blade (1000 pieces) | ||
44 | M52534270 | 3427 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | SPIFE Urine/CSF Protein Accessories (50 templates plus blotters) | ||
45 | M52534260 | 3426 | JBD | SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN | 2 | QuickGel Accessory Kit | ||
46 | M52534250 | 3425 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | SPE Abnormal Control (10 x 2 mL) | ||
47 | M52530580 | 3058 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | TITAN GEL Alkaline Phosphatase Kit | ||
48 | M52530410 | 3041 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | TITAN GEL Serum Protein Kit | ||
49 | M52530240 | 3024 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | Titan III Cellulose Acetate (94 x 76 mm) | ||
50 | M52523190 | 2319 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | SPIFE 4000 Applicator Blades |
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 |