| 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 | 00843876000558 | CCCF08 | CCCF08 | CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantita CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use | CRYOcheck Factor VIII Chromogenic | PRECISION BIOLOGIC INC |
| 2 | 00843876000503 | CCIK08 | The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older. | CRYOcheck™ FVIII Inhibitor Kit | PRECISION BIOLOGIC INC | |
| 3 | 00843876000497 | CSD | C & S Diluent | PRECISION BIOLOGIC INC | ||
| 4 | 00843876000428 | CCS-30 | CRYOcheck™ Clot S™ | PRECISION BIOLOGIC INC | ||
| 5 | 00843876000411 | CCS-15 | CRYOcheck™ Clot S™ | PRECISION BIOLOGIC INC | ||
| 6 | 00843876000404 | CCC-30 | CRYOcheck™ Clot C™ | PRECISION BIOLOGIC INC | ||
| 7 | 00843876000398 | CCC-15 | CRYOcheck™ Clot C™ | PRECISION BIOLOGIC INC | ||
| 8 | 00842768039522 | 10873458 | OPGL07 | For the quantitative determination of free protein S antigen in human plasma col For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer. | INNOVANCE Free PS Ag | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 9 | 00842768038211 | 10714565 | OUBD39 | Determination of ristocetin co-factor activity of von Willebrand factor in human Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination | BC von Willebrand Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 10 | 00842768011917 | 10446500 | OUVV17 | Quantative determination of protein C activity as an aid in the diagnosis of inh Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies | Berichrom® Protein C | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 11 | 00842768011900 | 10446499 | OUVV15 | Quantative determination of protein C activity as an aid in the diagnosis of inh Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies | Berichrom® Protein C | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 12 | 00842768011160 | 10446427 | OUBU15 | Quantative determination of a2-antiplasmin activity as an aid in the diagnosis o Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy | Berichrom® a2-Antiplasmin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 13 | 00842768008641 | 10446185 | OQYG11 | Coagulation test for the quantitative determination of protein C activity in human plasma | Protein C Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 14 | 00842768006678 | 10445968 | OPAP03 | Determination of the functional activity of protein S in human plasma | Protein S Ac | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 15 | 00842768004032 | 10445729 | B4238-40 | Determination of Factor VIII (antihemophilic factor) activity in human plasma | Factor VIII Chromogenic Assay | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 16 | 00811476010291 | 299-3 | vW Reference Plasma Normal | Chrono-log | CHRONO-LOG CORP | |
| 17 | 00811476010161 | 299 | Ristocetin Cofactor Assay Kit | Chrono-log | CHRONO-LOG CORP | |
| 18 | 00811476010130 | 299-5 | Tris Buffered Saline | Chrono-log | CHRONO-LOG CORP | |
| 19 | 00811476010123 | 299-2 | Lyophilized Human Platelets 6mL, TBS 12mL | Chrono-log | CHRONO-LOG CORP | |
| 20 | 00811476010017 | 299-4 | vW Reference Plasma Deficient | Chrono-log | CHRONO-LOG CORP | |
| 21 | 00811476010000 | 299-1 | Ristocetin 7.5 mg/Vial | Chrono-log | CHRONO-LOG CORP | |
| 22 | 13607450007258 | 00725 | STA® - Deficient VIII | DIAGNOSTICA STAGO | ||
| 23 | 10888234500346 | 403596 | 403596 | For Use with Factor VIII Antibody Screen | Positive Control | IMMUCOR GTI DIAGNOSTICS, INC. |
| 24 | 10888234500339 | 403593 | 403593 | For Use with Factor VIII Antibody Screen | Negative Control | IMMUCOR GTI DIAGNOSTICS, INC. |
| 25 | 10888234500322 | 403591 | 403591 | For Use with Factor VIII Antibody Screen | Kit Control | IMMUCOR GTI DIAGNOSTICS, INC. |
| 26 | 10888234500001 | F8S | F8S | The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immun The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect reactive with recombinant human factor VIII (FVIII) in human serum and plasma. | Factor VIII Antibody Screen | IMMUCOR GTI DIAGNOSTICS, INC. |
| 27 | 10629009020009 | FIX-AG | 96 Test enzyme immunoassay kit for the determination of FIX Antigen | VisuLize Factor FIX Antigen Kit | AFFINITY BIOLOGICALS INC | |
| 28 | 10629009010000 | FVIII-AG | 96 Test enzyme immunoassay kit for the determination of FVIII Antigen | VisuLize Factor FVIII Antigen Kit | AFFINITY BIOLOGICALS INC | |
| 29 | M52553730 | 5373 | Ristocetin Cofactor Abnormal Control Plasma | HELENA LABORATORIES CORPORATION | ||
| 30 | M52553720 | 5372 | Helena Ristocetin - 10 mg/mL | HELENA LABORATORIES CORPORATION | ||
| 31 | M52553710 | 5371 | Lyophilized Platelets | HELENA LABORATORIES CORPORATION | ||
| 32 | M52553700 | 5370 | Ristocetin Cofactor Assay Kit | HELENA LABORATORIES CORPORATION | ||
| 33 | M52553650 | 5365 | Tris-Buffered Saline | HELENA LABORATORIES CORPORATION | ||
| 34 | M52553630 | 5363 | Free Protein S Reagent | HELENA LABORATORIES CORPORATION | ||
| 35 | M52553610 | 5361 | von Willebrand Factor Antigen Rocket Kit | HELENA LABORATORIES CORPORATION | ||
| 36 | M52553600 | 5360 | Rocket Stain | HELENA LABORATORIES CORPORATION | ||
| 37 | M52553590 | 5359 | Protein S Antigen Rocket Kit | HELENA LABORATORIES CORPORATION | ||
| 38 | M52553580 | 5358 | Tris-Tricine Buffer | HELENA LABORATORIES CORPORATION | ||
| 39 | M52553570 | 5357 | Protein C Antigen Rocket Kit | HELENA LABORATORIES CORPORATION | ||
| 40 | M52553560 | 5356 | Lyophilized Platelets | HELENA LABORATORIES CORPORATION | ||
| 41 | M52552930 | 5293 | Monoclonal Free Protein S ELISA Kit | HELENA LABORATORIES CORPORATION | ||
| 42 | M52552920 | 5292 | Protein S ELISA Kit | HELENA LABORATORIES CORPORATION | ||
| 43 | M52552910 | 5291 | Protein C ELISA Kit | HELENA LABORATORIES CORPORATION | ||
| 44 | M52552900 | 5290 | von Willebrand Factor Antigen ELISA Kit (96 tests) | HELENA LABORATORIES CORPORATION | ||
| 45 | M52551970 | 5197 | Factor XII Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | ||
| 46 | M52551960 | 5196 | Factor XI Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | ||
| 47 | M52551950 | 5195 | Factor X Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | ||
| 48 | M52551940 | 5194 | Factor IX Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | ||
| 49 | M52551930 | 5193 | Factor VIII Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | ||
| 50 | M52551920 | 5192 | Factor VII Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION |