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 | 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. | GGN | Plasma, Coagulation Control | CRYOcheck Lupus Negative Control | |
37 | 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 | |
38 | 00843876000060 | RCN-10 | GIZ | Plasma, Control, Normal | CRYOcheck™ Reference Control Normal | |||
39 | 00843876000053 | RCN-05 | GIZ | Plasma, Control, Normal | CRYOcheck™ Reference Control Normal | |||
40 | 00843876000336 | FDP10-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor X Deficient Plasma | |||
41 | 00843876000329 | FDP10-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor X Deficient Plasma | |||
42 | 00843876000244 | FDP05-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor V Deficient Plasma | |||
43 | 00843876000275 | FDP08-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor VIII Deficient Plasma | |||
44 | 00843876000299 | FDP08-40 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor VIII Deficient Plasma | |||
45 | 00843876000282 | FDP08-15 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor VIII Deficient Plasma | |||
46 | 00843876000480 | SUR-10 | GIR | Reagent, Russel Viper Venom | CRYOcheck™ LA Sure™ | |||
47 | 00843876000237 | FDP05-10 | GJT | Plasma, Coagulation Factor Deficient | CRYOcheck™ Factor V Deficient Plasma | |||
48 | 00843876000138 | CCLF-10 | GGN | Plasma, Coagulation Control | CRYOcheck™ Low Fibrinogen Control | |||
49 | 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 |
50 | 00843876000183 | APCR-05 | GGN | Plasma, Coagulation Control | CRYOcheck™ APCR Positive Control |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 20812747018514 | 07-665US | Reagent QC Level 2 | Haemonetics TEG 6s | HAEMONETICS CORPORATION | |
2 | 20812747018491 | 07-664-US | Reagent QC Level 1 US | Haemonetics TEG 6s | HAEMONETICS CORPORATION | |
3 | 20763000014807 | 306-09POR | CONTROL 306-09POR PORC PUR/BLK 6L 10BX | N/A | MEDTRONIC, INC. | |
4 | 20613994923336 | 306-09POR | CONTROL 306-09POR PORC PUR/BLK 6L 10BX | NA | MEDTRONIC, INC. | |
5 | 15391521421101 | T4104 | TriniCHECK™ Abnormal control | TCOAG IRELAND LIMITED | ||
6 | 15391521420661 | T4203 | TriniCHECK™ Lupus Positive Control | TCOAG IRELAND LIMITED | ||
7 | 13607450011392 | 01139 | Pool Norm | DIAGNOSTICA STAGO | ||
8 | 10859394006184 | 35-201 | 35-201 | Assayed Reference Plasma L-2 10 x 1 ml | PlasmaRef ARL-2 | R 2 DIAGNOSTICS, INC. |
9 | 10859394006177 | 33-201 | 33-201 | Assayed Reference Plasma 10 x 1 ml | PlasmaRef ARN | R 2 DIAGNOSTICS, INC. |
10 | 10859394006139 | 150-201 | 150-201 | Positive control for LA 10 x 1 ml | PlasmaCon LA | R 2 DIAGNOSTICS, INC. |
11 | 10859394006122 | 150-200 | 150-200 | Positive control for LA 10 x 0.5 ml | PlasmaCon LA | R 2 DIAGNOSTICS, INC. |
12 | 10859394006115 | 86-201 | 86-201 | Venom Confirmatory test for LA 10 x 1 ml | LupoTek Correctin VL | R 2 DIAGNOSTICS, INC. |
13 | 10859394006108 | 85-202 | 85-202 | Venom Screening test of LA 10 x 2 ml | LupoTek Detectin VL | R 2 DIAGNOSTICS, INC. |
14 | 10859394006085 | 32-201 | 32-201 | Abnormal Control L-2 10 x 1 ml | PlasmaCon L2 | R 2 DIAGNOSTICS, INC. |
15 | 10859394006078 | 31-201 | 31-201 | Abnormal Control L-1 10 x 1 ml | PlasmaCon L1 | R 2 DIAGNOSTICS, INC. |
16 | 10859394006061 | 30-201 | 30-201 | Normal Control 10 x 1 ml | PlasmaCon N | R 2 DIAGNOSTICS, INC. |
17 | 10711234540046 | DCJ-005 | DCJ-005 | Protective Sleeves | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
18 | 10711234170373 | 000DCGLR-2 | 000DCGLR-2 | directCHECK GH100 ACTLR2 15/box | directCHECK ACT-LR Whole Blood Control, Level 2 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
19 | 10711234170366 | 000DCGLR-1 | 000DCGLR-1 | directCHECK GH100 ACTLRL1 15/box. | directCHECK ACT-LR Whole Blood Controls, Level 1 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
20 | 10711234170359 | 000DCGACT-2 | 000DCGACT-2 | directCHECK GH100 ACT+L2 15/box | directCHECK ACT+ Whole Blood Control, Level 2 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
21 | 10711234170342 | 000DCGACT-1 | 000DCGACT-1 | directCHECK GH100 ACT+L1 15/box | directCHECK ACT+ Whole Blood Control Level 1 | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
22 | 10711234170243 | DCJLR-N | DCJLR-N | directCHECK ACT-LR - Normal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
23 | 10711234170236 | DCJPT-N | DCJPT-N | directCHECK PT - Normal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
24 | 10711234170229 | DCJACT-N | DCJACT-N | directCHECK ACT+ Normal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
25 | 10711234170175 | DCJCAPTT-A | DCJCAPTT-A | directCHECK Citrate APTT - Abnormal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
26 | 10711234107102 | DCP214-A | DCP214-A | HepCheck P214 - Abnormal 15/box | HepCheck Whole Blood Control | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
27 | 10711234107096 | DCP214-N | DCP214-N | HepCheck P214 - Normal 15/box | HepCheck Whole Blood Control | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
28 | 10711234107089 | DCJLR-A | DCJLR-A | directCHECK ACT-LR Abnormal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
29 | 10711234107072 | DCJCPT-N | DCJCPT-N | directCHECK Citrate PT - Normal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
30 | 10711234107065 | DCJCPT-A | DCJCPT-A | directCHECK Citrate PT - Abnormal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
31 | 10711234107058 | DCJACT-A | DCJACT-A | directCHECK ACT+ Abnormal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
32 | 10711234107041 | DCJPT-A | DCJPT-A | directCHECK PT - Abnormal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
33 | 10711234107034 | DCJAPTT-A | DCJAPTT-A | directCHECK APTT - Abnormal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
34 | 10711234107027 | DCJAPTT-N | DCJAPTT-N | directCHECK APTT- Normal 15/box | directCHECK Whole Blood Controls | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
35 | 10711234102206 | QCACT | QCACT | ACT Whole Blood Quality Control 40/box | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
36 | 10629009131101 | LYNCP01 | A pool of normal citrated human plasma collected from a minimum of 20 donors, bu A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity. | VisuCon-L(TM) Normal Control Plasma | AFFINITY BIOLOGICALS INC | |
37 | 10629009121102 | LYABP01 | A pool of citrated normal human plasma collected from a minimum of 20 donors, an A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity. | VisuCon-L(TM) Abnormal Control Plasma | AFFINITY BIOLOGICALS INC | |
38 | 10629009111103 | LCSAB201 | A pool of citrated human plasma collected from a minimum of 20 donors that has b A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the highly abnormal range. | VisuCon-L Coag Screen ABN2 Plasma | AFFINITY BIOLOGICALS INC | |
39 | 10629009101104 | LCSAB101 | A pool of citrated human plasma collected from a minimum of 20 donors that has b A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed, and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the mid-level abnormal range. | VisuCon-L Coag Screen ABN1 Plasma | AFFINITY BIOLOGICALS INC | |
40 | 10629009091108 | LSCN01 | A pool of normal citrated human plasma collected from a minimum of 20 donors, bu A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT, APTT and Fibinogen) in the normal range. | VisuCon-L Coag Screen N Plasma | AFFINITY BIOLOGICALS INC | |
41 | 10629009084810 | FCSAB0481 | Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) in the mid-level abnormal range. | VisuCon-F Frozen Coag Screen ABN | AFFINITY BIOLOGICALS INC | |
42 | 10629009081819 | FCSAB0181 | Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range. | VisuCon-F Frozen Coag Screen ABN | AFFINITY BIOLOGICALS INC | |
43 | 10629009081253 | FCSAB0125 | Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the mid-level abnormal range. | VisuCon-F Frozen Coag Screen ABN | AFFINITY BIOLOGICALS INC | |
44 | 10629009074811 | FCSN0481 | Intended for use in the quality control of quantitative coagulation assays, incl Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. | VisuCon-F Frozen Coag Screen N | AFFINITY BIOLOGICALS INC | |
45 | 10629009071810 | FCSN0181 | Intended for the use in the quality control of quantitative coagulation assays, Intended for the use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. | VisuCon-F Frozen Coag Screen N | AFFINITY BIOLOGICALS INC | |
46 | 10629009071254 | FCSN0125 | Intended for the use in quality control of quantitative coagulation assays, incl Intended for the use in quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range. | VisuCon-F Frozen Coag Screen N | AFFINITY BIOLOGICALS INC | |
47 | 10629009061255 | FRABP0125 | Intended for use in the quality control of coagulation assays in the borderline Intended for use in the quality control of coagulation assays in the borderline pathological range. | VisuCon-F Frozen Abnormal Control Plasma | AFFINITY BIOLOGICALS INC | |
48 | 10629009061057 | FRABP0105 | Intended for use in the quality control of coagulation assays in the borderline Intended for use in the quality control of coagulation assays in the borderline pathological range. | VisuCon-F Frozen Abnormal Control Plasma | AFFINITY BIOLOGICALS INC | |
49 | 10629009051256 | FRNCP0125 | Intended for use in the quality control of coagulation assays in the normal range. | VisuCon-F Frozen Normal Control Plasma | AFFINITY BIOLOGICALS INC | |
50 | 10629009051058 | FRNCP0105 | Intended for use in the quality control of coagulation assays in the normal range. | VisuCon-F Frozen Calibrator Plasma | AFFINITY BIOLOGICALS INC |