No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00843876000268 | FDP07-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor VII Deficient Plasma | |||
2 | 00843876000312 | FDP09-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor IX Deficient Plasma | |||
3 | 00843876000305 | FDP09-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor IX Deficient Plasma | |||
4 | 00843876000251 | FDP07-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor VII Deficient Plasma | |||
5 | 00843876000381 | FDPK-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Prekallikrein Deficient Plasma | |||
6 | 00843876000435 | PNP-10 | GGW | Test, Time, Partial Thromboplastin | CRYOcheck™ Platelet Lysate | |||
7 | 00843876000046 | CCN-40 | GGN | Plasma, Coagulation Control | CRYOcheck™ Pooled Normal Plasma | |||
8 | 00843876000039 | CCN10-10 | GGN | Plasma, Coagulation Control | CRYOcheck™ Pooled Normal Plasma | |||
9 | 00843876000022 | CCN-15 | GGN | Plasma, Coagulation Control | CRYOcheck™ Pooled Normal Plasma | |||
10 | 00843876000015 | CCN-10 | GGN | Plasma, Coagulation Control | CRYOcheck™ Pooled Normal Plasma | |||
11 | 00843876000428 | CCS-30 | GGP | Test, Qualitative And Quantitative Factor Deficiency | CRYOcheck™ Clot S™ | |||
12 | 00843876000411 | CCS-15 | GGP | Test, Qualitative And Quantitative Factor Deficiency | CRYOcheck™ Clot S™ | |||
13 | 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. | GGN,GGP | Plasma, Coagulation Control,Test, Qualitative And Quantitative Factor Deficiency | 2 | CRYOcheck™ FVIII Inhibitor Kit | |
14 | 00843876000473 | CHK50-30 | GIR | Reagent, Russel Viper Venom | CRYOcheck™ LA Check™ | |||
15 | 00843876000466 | CHK80-10 | GIR | Reagent, Russel Viper Venom | CRYOcheck™ LA Check™ | |||
16 | 00843876000459 | CHK-40 | GIR | Reagent, Russel Viper Venom | CRYOcheck™ LA Check™ | |||
17 | 00843876000442 | CHK-10 | GIR | Reagent, Russel Viper Venom | CRYOcheck™ LA Check™ | |||
18 | 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 | GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | CRYOcheck Factor VIII Chromogenic |
19 | 00843876000220 | FDP02-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor II Deficient Plasma | |||
20 | 00843876000213 | FDP02-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor II Deficient Plasma | |||
21 | 00843876000176 | CCWLP-10 | GGC | Control, Plasma, Abnormal | CRYOcheck™ Weak Lupus Positive Control | |||
22 | 00843876000169 | CCWLP-05 | GGC | Control, Plasma, Abnormal | CRYOcheck™ Weak Lupus Positive Control | |||
23 | 00843876000152 | CCLP-10 | GGN,GGC | Plasma, Coagulation Control,Control, Plasma, Abnormal | CRYOcheck™ Lupus Positive Control | |||
24 | 00843876000145 | CCLP-05 | GGN,GGC | Plasma, Coagulation Control,Control, Plasma, Abnormal | CRYOcheck™ Lupus Positive Control | |||
25 | 00843876000091 | ARP2-10 | GGC,GGN | Control, Plasma, Abnormal,Plasma, Coagulation Control | CRYOcheck™ Abnormal 2 Reference Control | |||
26 | 00843876000084 | ARP1-10 | GGN,GGC | Plasma, Coagulation Control,Control, Plasma, Abnormal | CRYOcheck™ Abnormal 1 Reference Control | |||
27 | 00843876000077 | ARP1-05 | GGN,GGC | Plasma, Coagulation Control,Control, Plasma, Abnormal | CRYOcheck™ Abnormal 1 Reference Control | |||
28 | 00843876000374 | FDP12-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor XII Deficient Plasma | |||
29 | 00843876000367 | FDP12-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor XII Deficient Plasma | |||
30 | 00843876000497 | CSD | GGP | Test, Qualitative And Quantitative Factor Deficiency | C & S Diluent | |||
31 | 00843876000206 | CCNRP-10 | GGN | Plasma, Coagulation Control | CRYOcheck™ Normal Reference Plasma | |||
32 | 00843876000190 | CCNRP-05 | GGN | Plasma, Coagulation Control | CRYOcheck™ Normal Reference Plasma | |||
33 | 00843876000107 | CCA1-10 | GGC,GGN | Control, Plasma, Abnormal,Plasma, Coagulation Control | CRYOcheck™ Abnormal 1 Control | |||
34 | 00843876000404 | CCC-30 | GGP | Test, Qualitative And Quantitative Factor Deficiency | CRYOcheck™ Clot C™ | |||
35 | 00843876000398 | CCC-15 | GGP | Test, Qualitative And Quantitative Factor Deficiency | CRYOcheck™ Clot C™ | |||
36 | 00843876000534 | CCLN-10 | CCLN-10 | Prepared from human source plasma and recommended as a negative control in assay Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. | GGN | Plasma, Coagulation Control | CRYOcheck Lupus Negative Control | |
37 | 00843876000060 | RCN-10 | GIZ | Plasma, Control, Normal | CRYOcheck™ Reference Control Normal | |||
38 | 00843876000053 | RCN-05 | GIZ | Plasma, Control, Normal | CRYOcheck™ Reference Control Normal | |||
39 | 00843876000336 | FDP10-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor X Deficient Plasma | |||
40 | 00843876000329 | FDP10-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor X Deficient Plasma | |||
41 | 00843876000244 | FDP05-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor V Deficient Plasma | |||
42 | 00843876000275 | FDP08-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor VIII Deficient Plasma | |||
43 | 00843876000299 | FDP08-40 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor VIII Deficient Plasma | |||
44 | 00843876000282 | FDP08-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor VIII Deficient Plasma | |||
45 | 00843876000480 | SUR-10 | GIR | Reagent, Russel Viper Venom | CRYOcheck™ LA Sure™ | |||
46 | 00843876000237 | FDP05-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor V Deficient Plasma | |||
47 | 00843876000138 | CCLF-10 | GGN | Plasma, Coagulation Control | CRYOcheck™ Low Fibrinogen Control | |||
48 | 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. | GFO | Activated Partial Thromboplastin | 2 | CRYOcheck Hex LA |
49 | 00843876000183 | APCR-05 | GGN | Plasma, Coagulation Control | CRYOcheck™ APCR Positive Control | |||
50 | 00843876000343 | FDP11-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor XI Deficient Plasma |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00859110005111 | 903se | 903se | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activity on automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
2 | 00859110005104 | 903st | 903st | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
3 | 00859110005098 | 903il | 903il | Validate Heparin is intended for the quantitative determination of Calibration V Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
4 | 00859110005081 | 902se | 902se | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
5 | 00859110005074 | 902st | 902st | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
6 | 00859110005067 | 902il | 902il | Validate D-Dimer is intended for the quantitative determination of Calibration V Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
7 | 00850201006208 | 840C | 840C | ACTICLOT Protein C Resistance control plasmas | BIOMEDICA ADI INC. | |
8 | 00847661004516 | 27102X | 27102X | Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
9 | 00847661004509 | 27103 | 27103 | Liquichek D-dimer Control Level 3 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
10 | 00847661004493 | 27102 | 27102 | Liquichek D-dimer Control Level 2 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
11 | 00847661004486 | 27101 | 27101 | Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
12 | 00847661004479 | 27100 | 27100 | Liquichek D-dimer Control Level Low (A processed human plasma assayed D-dimer control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
13 | 00847661001959 | 745X | 745X | Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulatio Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
14 | 00847661001898 | 598X | 598X | Lyphochek Hemostasis Control MiniPak (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
15 | 00847661001041 | 599 | 599 | Lyphochek Hemostasis Control Level 3 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
16 | 00847661001034 | 598 | 598 | Lyphochek Hemostasis Control Level 2 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
17 | 00847661001027 | 597 | 597 | Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
18 | 00847661000792 | 746 | 746 | Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
19 | 00847661000785 | 745 | 745 | Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
20 | 00847661000778 | 744 | 744 | Lyphochek Coagulation Control Level 1 (A human plasma coagulation control.) | Lyphochek | BIO-RAD LABORATORIES, INC. |
21 | 00845275000832 | 100603 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
22 | 00845275000818 | 100560 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
23 | 00845275000689 | 100013 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
24 | 00845275000658 | 100312 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
25 | 00845275000634 | 100308 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
26 | 00845275000610 | 100607 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
27 | 00845275000603 | 100604 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
28 | 00845275000504 | 100301 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
29 | 00843876000541 | CCLN-05 | CCLN-05 | Prepared from human source plasma and recommended as a negative control in assay Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. | CRYOcheck Lupus Negative Control | PRECISION BIOLOGIC INC |
30 | 00843876000534 | CCLN-10 | CCLN-10 | Prepared from human source plasma and recommended as a negative control in assay Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. | CRYOcheck Lupus Negative Control | PRECISION BIOLOGIC INC |
31 | 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 | |
32 | 00843876000206 | CCNRP-10 | CRYOcheck™ Normal Reference Plasma | PRECISION BIOLOGIC INC | ||
33 | 00843876000190 | CCNRP-05 | CRYOcheck™ Normal Reference Plasma | PRECISION BIOLOGIC INC | ||
34 | 00843876000183 | APCR-05 | CRYOcheck™ APCR Positive Control | PRECISION BIOLOGIC INC | ||
35 | 00843876000152 | CCLP-10 | CRYOcheck™ Lupus Positive Control | PRECISION BIOLOGIC INC | ||
36 | 00843876000145 | CCLP-05 | CRYOcheck™ Lupus Positive Control | PRECISION BIOLOGIC INC | ||
37 | 00843876000138 | CCLF-10 | CRYOcheck™ Low Fibrinogen Control | PRECISION BIOLOGIC INC | ||
38 | 00843876000114 | CCA2-10 | 00843876010113 | CRYOcheck™ Abnormal 2 Control | PRECISION BIOLOGIC INC | |
39 | 00843876000107 | CCA1-10 | CRYOcheck™ Abnormal 1 Control | PRECISION BIOLOGIC INC | ||
40 | 00843876000091 | ARP2-10 | CRYOcheck™ Abnormal 2 Reference Control | PRECISION BIOLOGIC INC | ||
41 | 00843876000084 | ARP1-10 | CRYOcheck™ Abnormal 1 Reference Control | PRECISION BIOLOGIC INC | ||
42 | 00843876000077 | ARP1-05 | CRYOcheck™ Abnormal 1 Reference Control | PRECISION BIOLOGIC INC | ||
43 | 00843876000046 | CCN-40 | CRYOcheck™ Pooled Normal Plasma | PRECISION BIOLOGIC INC | ||
44 | 00843876000039 | CCN10-10 | CRYOcheck™ Pooled Normal Plasma | PRECISION BIOLOGIC INC | ||
45 | 00843876000022 | CCN-15 | CRYOcheck™ Pooled Normal Plasma | PRECISION BIOLOGIC INC | ||
46 | 00843876000015 | CCN-10 | CRYOcheck™ Pooled Normal Plasma | PRECISION BIOLOGIC INC | ||
47 | 00842768017100 | 10873534 | OPOE05 | For quality control of the INNOVANCE® Heparin assay | INNOVANCE Heparin LMW Control 1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
48 | 00842768017094 | 10873533 | OPOF05 | For quality control of the INNOVANCE® Heparin assay | INNOVANCE Heparin LMW Control 2 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
49 | 00842768017087 | 10873532 | OPOD05 | For quality control of the INNOVANCE® Heparin assay | INNOVANCE Heparin UF Control 2 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
50 | 00842768017070 | 10873531 | OPOC05 | For quality control of the INNOVANCE® Heparin assay | INNOVANCE Heparin UF Control 1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |