No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 13607450007388 | 00738 | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | STA® - Deficient X | |||
2 | 13607450007234 | 00723 | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | STA® - Deficient XI | |||
3 | 13607450006145 | 00614 | JCO | BOTHROPS ATROX REAGENT | STA® - Reptilase® | |||
4 | 13607450005209 | 00520 | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | STA® - VWF:Ag Calibrator | |||
5 | 03607450581041 | 58104 | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | STA Satellite® | ||
6 | 03607450009484 | 00948 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Asserachrom® tPA | ||
7 | 03607450009477 | 00947 | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Asserachrom® D-Di | ||
8 | 03607450008579 | 00857 | JBN | Fibrin monomer paracoagulation | 2 | F.S. Test | ||
9 | 03607450007466 | 00746 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | STA® - Staclot® Protein S | ||
10 | 03607450006780 | 00678 | GGN,GGC | PLASMA, COAGULATION CONTROL,CONTROL, PLASMA, ABNORMAL | 2 | STA® - System Control N + P | ||
11 | 03607450006674 | 00667 | GJS | TEST, TIME, PROTHROMBIN | 2 | STA® - Néoplastine® CI Plus 10 | ||
12 | 03607450006063 | 00606 | GJS | TEST, TIME, PROTHROMBIN | 2 | STA® - Néoplastine® CI Plus 5 | ||
13 | 03607450582307 | 58230 | GKP | INSTRUMENT, COAGULATION, AUTOMATED | 2 | ST art® | ||
14 | 03607450007374 | 00737 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | STA® - Staclot® Protein C 3 | ||
15 | 03607450006001 | 00600 | GFO | ACTIVATED PARTIAL THROMBOPLASTIN | 2 | Staclot® LA | ||
16 | 03607450005943 | 00594 | GFO | ACTIVATED PARTIAL THROMBOPLASTIN | 2 | Staclot® LA 20 | ||
17 | 03607450005684 | 00568 | JBQ | ANTITHROMBIN III QUANTITATION | 2 | Liatest® AT III | ||
18 | 03607450002010 | 00201 | GGC,GGN | CONTROL, PLASMA, ABNORMAL,PLASMA, COAGULATION CONTROL | 2 | STA® - Control LA 1 + 2 | ||
19 | 13607450007258 | 00725 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | STA® - Deficient VIII | |||
20 | 13607450007241 | 00724 | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | STA® - Deficient IX | |||
21 | 13607450005414 | 00541 | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | FDP Plasma (Latex) | |||
22 | 13607450003335 | 00333 | GIR | REAGENT, RUSSEL VIPER VENOM | STA® - Staclot® dRVV Screen 5 | |||
23 | 03607450009439 | 00943 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Asserachrom® IX:Ag | ||
24 | 03607450009064 | 00906 | KFF | ASSAY, HEPARIN | 2 | Stachrom® Heparin | ||
25 | 03607450007473 | 00747 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | STA® - Staclot® Protein C 1 | ||
26 | 03607450006834 | 00683 | KFF | ASSAY, HEPARIN | 2 | STA® - Heparin Control | ||
27 | 03607450006773 | 00677 | GGN | PLASMA, COAGULATION CONTROL | 2 | STA® - Coag Control (N + ABN) PLUS | ||
28 | 03607450006766 | 00676 | GGC,GGN | CONTROL, PLASMA, ABNORMAL,PLASMA, COAGULATION CONTROL | 2 | STA® - Coag Control N + ABN | ||
29 | 03607450006599 | 00659 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | STA® - Stachrom® Antiplasmin | ||
30 | 03607450006582 | 00658 | DDX | PLASMINOGEN, ANTIGEN, ANTISERUM, CONTROL | 1 | STA® - Stachrom® Plasminogen | ||
31 | 03607450005974 | 00597 | GGW | TEST, TIME, PARTIAL THROMBOPLASTIN | 2 | STA® - C.K. Prest® 5 | ||
32 | 03607450005189 | 00518 | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | 2 | STA® - Liatest® VWF:Ag | ||
33 | 03607450005165 | 00516 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | STA® - Liatest® Free Protein S 6 | ||
34 | 03607450004540 | 00454 | GHH | FIBRIN SPLIT PRODUCTS | 2 | D-Di Test® | ||
35 | 03607450003482 | 00348 | JIS | CALIBRATOR, PRIMARY | 2 | STA® - Multi Hep Calibrator | ||
36 | 13607450011392 | 01139 | GGN | PLASMA, COAGULATION CONTROL | Pool Norm | |||
37 | 13607450007449 | 00744 | GJS,GJT | TEST, TIME, PROTHROMBIN,PLASMA, COAGULATION FACTOR DEFICIENT | STA® - Deficient V | |||
38 | 13607450006749 | 00674 | KQJ | SYSTEM, FIBRINOGEN DETERMINATION | STA® - Fibrinogen 5 | |||
39 | 13607450006114 | 00611 | GJA | TEST, THROMBIN TIME | STA® - Thrombin 2 | |||
40 | 13607450003670 | 00367 | PPM | General purpose reagent | STA® - CaCl2 0.025 M | |||
41 | 03607450590272 | 59027 | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | STA R Max® (with cap piercing option) | ||
42 | 03607450590104 | 59010 | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | STA R Max® (with cap piercing option) | ||
43 | 03607450011784 | 00311US | KFF | ASSAY, HEPARIN | 2 | STA® - Liquid Anti-Xa 4 | ||
44 | 03607450009514 | 00951 | LCO | PLATELET FACTOR 4 RADIOIMMUNOASSAY | 2 | Asserachrom® PF4 | ||
45 | 03607450009460 | 00946 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Asserachrom® Free Protein S | ||
46 | 03607450009453 | 00945 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Asserachrom® Total Protein S | ||
47 | 03607450009422 | 00942 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Asserachrom® VWF:Ag | ||
48 | 03607450006810 | 00681 | KFF | ASSAY, HEPARIN | 2 | STA® - Hepanorm® HBPM/LMWH | ||
49 | 03607450006056 | 00605 | GJS | TEST, TIME, PROTHROMBIN | 2 | STA® - Néoplastine® CI 5 | ||
50 | 03607450005400 | 00540 | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | FDP Plasma |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 13607450012627 | 00599US | PTT-LA | DIAGNOSTICA STAGO | ||
2 | 13607450005995 | 00599 | PTT-LA | DIAGNOSTICA STAGO | ||
3 | 13607450005957 | 00595 | STA® - PTT A 5 | DIAGNOSTICA STAGO | ||
4 | 10859394006238 | 21-405 | 21-405 | APTT reagent 5 x 5 ml | Phospholin ES w/Calcium | R 2 DIAGNOSTICS, INC. |
5 | 10859394006146 | 87-305 | 87-305 | Screening test for LA 250 DET | LupoTek KCT | R 2 DIAGNOSTICS, INC. |
6 | 10859394006016 | 21-410 | 21-410 | APTT reagent 5 x 10 ml with 5 Calcium Chloride | Phospholin ES w/ Calcium Chloride | R 2 DIAGNOSTICS, INC. |
7 | M52551870 | 5187 | AB-TROL 2 Coagulation Control | HELENA LABORATORIES CORPORATION | ||
8 | 08426950088929 | 82 2668 63 | 82 2668 63 | Coatest APCR Control Plasma Level 2 | Coatest APCR Control Plasma Level 2 | INSTRUMENTATION LABORATORY COMPANY |
9 | 08426950088912 | 82 2650 63 | 82 2650 63 | Coatest APCR Control Plasma Level 1 | Coatest APCR Control Plasma Level 1 | INSTRUMENTATION LABORATORY COMPANY |
10 | 08426950087656 | 00020008800 | 00020008800 | HemosIL Factor V Reagent Plasma (for APC R V) | HemosIL Factor V Reagent Plasma (for APC R V) | INSTRUMENTATION LABORATORY COMPANY |
11 | 08426950076100 | 82 3138 63 | 82 3138 63 | Coatest APC Resistance V-S | Coatest APC Resistance V-S | INSTRUMENTATION LABORATORY COMPANY |
12 | 08426950062424 | 00020008700 | 00020008700 | HemosIL Factor V Leiden (APC Resistance V) | HemosIL Factor V Leiden (APC Resistance V) | INSTRUMENTATION LABORATORY COMPANY |
13 | 08426950060147 | 82 2643 63 | 82 2643 63 | Coatest APC Resistance | Coatest APC Resistance | INSTRUMENTATION LABORATORY COMPANY |
14 | 08426950060017 | 82 3120 63 | 82 3120 63 | Coatest APC Resistance V | Coatest APC Resistance V | INSTRUMENTATION LABORATORY COMPANY |
15 | 07640175460013 | 502-02 | 502-02 | Plasma based functional assay for the determination of resistance to activated p Plasma based functional assay for the determination of resistance to activated protein C caused by the Factor V Leiden mutation (FV:Q506). | Pefakit | DSM NUTRITIONAL PRODUCTS AG ZWEIGNIEDERLASSUNG PENTAPHARM |
16 | 03663537017964 | CK065K | CK065K | HEMOCLOT Quanti. V-L | HYPHEN BIOMED | |
17 | 03607450005974 | 00597 | STA® - C.K. Prest® 5 | DIAGNOSTICA STAGO | ||
18 | 00855360006045 | 023-001 | 023-001 | INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG or IgM labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of aCL antibodies. Results are obtained by reading the O.D. of each test well with a spectrophotometer. Calibrator sera are provided, with the IgG and IgM aCL concentrations expressed in GPL or MPL units, respectively. The O.D. values of all the other samples are multiplied by the conversion factors to obtain IgG and IgM aCL antibody concentrations in standard units. Control and patient results are determined from the calibration curve. Refer to Product Product Insert. | REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
19 | 00850201006192 | 840 | 840 | ACTICLOT Protein C Resistance Kit | BIOMEDICA ADI INC. | |
20 | 00843876000435 | PNP-10 | CRYOcheck™ Platelet Lysate | PRECISION BIOLOGIC INC | ||
21 | 00842768033520 | 10459420 | OQYI11 | Russell Viper Venom-based test for screening of resistance to Activated Protein Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect | Factor V Leiden | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
22 | 00842768003882 | 10445714 | B4219-2 | Liquid purified soy and rabbit brain phosphatides with plasma activator for coag Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time | Dade® Actin® FSL Activated PTT Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
23 | 00842768003875 | 10445713 | B4219-1 | Liquid purified soy and rabbit brain phosphatides with plasma activator for coag Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time | Dade® Actin® FSL Activated PTT Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
24 | 00842768003868 | 10445712 | B4218-20 | Liquid purified soy phosphatides with plasma activator for coagulation procedure Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time | Dade® Actin® FS Activated PTT Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
25 | 00842768003844 | 10445710 | B4218-100 | Liquid purified soy phosphatides with plasma activator for coagulation procedure Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time | Dade® Actin® FS Activated PTT Reagent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |