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 | 00817869020014 | CR-121-1 | CR-121-1 | Slide Platelet Aggregation Test Reagent | ANALYTICAL CONTROL SYSTEMS INC | |
2 | 00627944000103 | 10 mL | QuikCoag Calcium Choride 0.02M | BIOMEDICA DIAGNOSTICS INC | ||
3 | 00627944000097 | 4 mL | QuikCoag Calcium Chloride 0.02M | BIOMEDICA DIAGNOSTICS INC | ||
4 | 00627944000059 | 10 mL | QuikCoag APTT-EA | BIOMEDICA DIAGNOSTICS INC | ||
5 | 00627944000042 | 4 mL | QuikCoag APTT-EA | BIOMEDICA DIAGNOSTICS INC | ||
6 | 15391521420517 | T1902 | TriniCLOT™ Calcium Chloride 0.025M | TCOAG IRELAND LIMITED | ||
7 | 15391521420340 | T1206 | TriniCLOT™ Automated aPTT 3 mL | TCOAG IRELAND LIMITED | ||
8 | 15391521420333 | T1205 | TriniCLOT™ Automated aPTT 6 mL | TCOAG IRELAND LIMITED | ||
9 | 13607450003106 | 00310 | STA® - Cephascreen® 10 | DIAGNOSTICA STAGO | ||
10 | 13607450003083 | 00308 | STA® - Cephascreen® 4 | DIAGNOSTICA STAGO | ||
11 | 10711234103029 | J103C | J103C | Citrate APTT Cuvette - 45 test cuvettes/box. | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
12 | M52553890 | 5389 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | ||
13 | M52553880 | 5388 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | ||
14 | M52553870 | 5387 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | ||
15 | M52553860 | 5386 | 0.25 M Calcium Chloride | HELENA LABORATORIES CORPORATION | ||
16 | 08426950915676 | 06260036000 | 06260036000 | GEM TEST APTT CITRATE | GEM TEST APTT CITRATE | INSTRUMENTATION LABORATORY COMPANY |
17 | 08426950433491 | 00020004800 | 00020004800 | HemosIL Silica Clotting Time | HemosIL Silica Clotting Time | INSTRUMENTATION LABORATORY COMPANY |
18 | 08426950087649 | 00020007400 | 00020007400 | HemosIL SynthAFax | HemosIL SynthAFax | INSTRUMENTATION LABORATORY COMPANY |
19 | 08426950087632 | 00020006900 | 00020006900 | HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) | HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) | INSTRUMENTATION LABORATORY COMPANY |
20 | 08426950078937 | 00020006300 | 00020006300 | HemosIL APTT-SP | HemosIL APTT-SP | INSTRUMENTATION LABORATORY COMPANY |
21 | 08426950078920 | 00020006800 | 00020006800 | HemosIL SynthASil | HemosIL SynthASil | INSTRUMENTATION LABORATORY COMPANY |
22 | 08426950023487 | 00019741910 | 00019741910 | HemosIL Calcium Chloride 0.025M (for APTT-SP kit) | HemosIL Calcium Chloride 0.025M (for APTT-SP kit) | INSTRUMENTATION LABORATORY COMPANY |
23 | 05391521420305 | T1202 | TriniCLOT™ aPTT S 3 mL | TCOAG IRELAND LIMITED | ||
24 | 05391521420299 | T1201 | TriniCLOT™ aPTT S 10 mL | TCOAG IRELAND LIMITED | ||
25 | 03607450006001 | 00600 | Staclot® LA | DIAGNOSTICA STAGO | ||
26 | 03607450005943 | 00594 | Staclot® LA 20 | DIAGNOSTICA STAGO | ||
27 | 00845275000771 | 100314 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
28 | 00845275000764 | 100309 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
29 | 00845275000665 | 100403 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
30 | 00845275000641 | 100402 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
31 | 00845275000511 | 100304 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
32 | 00843876000527 | Hex LA-7 | HEXLA-7 | CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intend CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations. | CRYOcheck Hex LA | PRECISION BIOLOGIC INC |
33 | 00843876000510 | Hex LA | Hex LA | CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intend CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations. | CRYOcheck Hex LA | PRECISION BIOLOGIC INC |
34 | 00842768007538 | 10446067 | OQGS35 | Determination of the activated partial thromboplastin time (APTT) in citrated human plasma | Pathromtin® SL | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
35 | 00842768007521 | 10446066 | OQGS29 | Determination of the activated partial thromboplastin time (APTT) in citrated human plasma | Pathromtin® SL | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
36 | 00842768003851 | 10445711 | B4218-2 | Liquid rabbit brain cephalin with plasma activator for coagulation procedures re Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time | Dade® Actin® Activated Cephaloplastin Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
37 | 00842768003837 | 10445709 | B4218-1 | Liquid rabbit brain cephalin with plasma activator for coagulation procedures re Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time | Dade® Actin® Activated Cephaloplastin Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |