| 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 | 00861900000398 | 100218 | 03P56-50 | Test Strip Kit, 50 ct. | Coag-Sense Test Strip Kit, 50 ct. | COAGUSENSE INC. |
| 2 | 00861900000381 | 200221 | 03P70-01 | Coag-Sense PT/INR Patient Self-Test System | Coag-Sense PT/INR Patient Self-Test System | COAGUSENSE INC. |
| 3 | 00861900000374 | 200222 | 03P70-02 | Coag-Sense PT/INR Professional System | Coag-Sense PT/INR Professional System | COAGUSENSE INC. |
| 4 | 00861900000350 | 200107 | 03P73-01 | Coag-Sense PT/INR Meter | Coag-Sense PT/INR Meter | COAGUSENSE INC. |
| 5 | 00861900000343 | 100250 | 03P69-10 | Coag-Sense Professional Control Test Strip Kit - 10 Ct | Coag-sense | COAGUSENSE INC. |
| 6 | 00861900000336 | 100218 | 03P56-50 | Coag-Sense Test Strip Kit - 50 Ct | Coag-sense | COAGUSENSE INC. |
| 7 | 00861900000329 | 100221 | 03P50-01 | Coag-Sense PT/INR Patient Self-Test System | Coag-sense | COAGUSENSE INC. |
| 8 | 00861900000312 | 100222 | 03P60-01 | Coag-Sense PT/INR Professional System | Coag-sense | COAGUSENSE INC. |
| 9 | 00861900000305 | 100107 | 03P63-01 | Coag-Sense PT/INR Meter | Coag-Sense | COAGUSENSE INC. |
| 10 | 00860007370878 | 03F73-05 | 06F73-05 | Coag-Sense PT/INR Professional 5-Box Promo | Coag-sense | COAGUSENSE INC. |
| 11 | 00860007370861 | 03F73-03 | 06F73-03 | Coag-Sense PT/INR Professional 3-Box Promo | Coag-sense | COAGUSENSE INC. |
| 12 | 00850201006055 | 824 | 824 | ACTICLOT dPT | BIOMEDICA ADI INC. | |
| 13 | 00845275000801 | 100362 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
| 14 | 00845275000795 | 100357 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
| 15 | 00845275000542 | 100356 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
| 16 | 00845275000535 | 100354 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
| 17 | 00845275000528 | 100353 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
| 18 | 00842768011337 | 10446445 | OUHP49 | Determination of prothrombin time (PT) and of the activity of coagulation factor Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X | Thromborel® S | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 19 | 00842768011306 | 10446442 | OUHP29 | Determination of prothrombin time (PT) and of the activity of coagulation factor Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X | Thromborel® S | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 20 | 00842768003806 | 10445706 | B4212-50 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 21 | 00842768003790 | 10445705 | B4212-40 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 22 | 00842768003783 | 10445704 | B4212-100 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 23 | 00630414034348 | 11065645 | 11065645 | Xprecia™ System PT/INR Strips, is intended for use by professional healthcare pr Xprecia™ System PT/INR Strips, is intended for use by professional healthcare providers to provide an INR (International NormalizedRatio) based on a prothrombin time (PT) response for the monitoring of oral anticoagulation therapy with warfarin | Xprecia™ System PT/INR Strips | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 24 | 00630414025148 | 11065584 | 11065584 | The Xprecia Stride™ Coagulation System is intended for use by professional healt The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin. | Xprecia Stride™ Coagulation Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 25 | 00630414023496 | 10873568 | B4212-101 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 26 | 00630414023489 | 10873567 | B4212-51 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 27 | 00630414023472 | 10873566 | B4212-41 | For use in prothrombin time (PT) determinations and prothrombin time-based assay For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma | Dade® Innovin® | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 28 | 00630414023465 | 10873565 | OUHP53 | Determination of prothrombin time (PT) and of the activity of coagulation factor Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X | Thromborel® S | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 29 | 00630414023441 | 10873564 | OUHP31 | Determination of prothrombin time (PT) and of the activity of coagulation factor Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X | Thromborel® S | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 30 | 00627944000035 | 10 mL | QuikCoag PT-HS | BIOMEDICA DIAGNOSTICS INC | ||
| 31 | 00627944000028 | 4 mL | QuikCoag PT-HS | BIOMEDICA DIAGNOSTICS INC | ||
| 32 | 00627944000011 | 2 mL | QuikCoag PT-HS | BIOMEDICA DIAGNOSTICS INC | ||
| 33 | 00385480498487 | PHOX PLUS | 49848 | Stat Profile pHOx Plus Air Detector | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 34 | 00385480347174 | PHOX PLUS L | 34717 | Remanufactured Stat Profile pHOx Plus L Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 35 | 00385480346436 | PHOX PLUS/C | 34643 | STAT PROFILE pHOx PLUS/C PROBE | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 36 | 00385480340816 | PHOX PLUS L | 34081 | Stat Profile pHOx Plus L Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 37 | 00385480322041 | PHOX PLUS | 32204 | Remanufactured Stat Profile pHOx Plus Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 38 | 00385480278072 | PHOX PLUS | 27807 | STAT PROFILE pHOx PLUS SENSOR MODULE REPLACEMENT | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 39 | 00385480278034 | PHOX PLUS | 27803 | Stat Profile pHOx Plus Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 40 | 00385480248198 | CCX/PHOX/BASIC/PLUS/L/C | 24819 | Stat Profile CCX Stat Profile pHOx/Basic/Plus/L/C/M Control Flush Fixture | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 41 | 00385480243278 | PHOX/BASIC/PLUS/L/C | 24327 | STAT PROFILE pHOx/BASIC/PLUS/L/C FLUSH FIXTURE | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 42 | 00385480225076 | pHOx/BASIC/PLUS/L/C | 22507 | STAT PROFILE pHOx/BASIC/PLUS/L/C SENSOR | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 43 | 00385480214971 | pHOx/BASIC/PLUS/L/C | 21497 | STAT PROFILE pHOx/BASIC/PLUS/L/C REFERENCE LINE ASSEMBLY | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
| 44 | 00365702700499 | 07729952160 | 07729952160 | CoaguChek Vantus (USA) | CoaguChek Vantus System | ROCHE DIAGNOSTICS GMBH |
| 45 | 00365702398108 | 5530199160 | 5530199160 | CoaguChek XS Pro Kit | ROCHE DIAGNOSTICS GMBH | |
| 46 | 00365702164109 | 5021537001 | 5021537001 | CoaguChek XS Plus Professional Care Kit | ROCHE DIAGNOSTICS GMBH | |
| 47 | 00365702128101 | 4625315160 | 4625315160 | CoaguChek XS PT strips | ROCHE DIAGNOSTICS GMBH | |
| 48 | 00365702127104 | 4625374160 | 4625374160 | COAGUCHEK XS PT TEST 6 STRIP | ROCHE DIAGNOSTICS GMBH | |
| 49 | 00365702126107 | 4837975001 | 4837975001 | CoaguChek XS Professional Use Care Kit | ROCHE DIAGNOSTICS GMBH | |
| 50 | 00365702125100 | 4837738001 | 4837738001 | CoaguChek XS Patient Self Testing Care Kit | ROCHE DIAGNOSTICS GMBH |