No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817869020359 | HC-121 | HC-121 | Hemoglobin Variant Control Kit | ||||
2 | 00817869020175 | HC-110LIN | HC-110LIN | KHG | Whole Blood Hemoglobin Determination | Hemoglobin Total Linearity Control | ||
3 | 00817869020304 | SC-132 | SC-132 | JIS | Calibrator, Primary | 2 | ACE Calibrator | |
4 | 00817869020267 | SC-126 | SC-126 | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Whole Blood Control Level II | |
5 | 00817869020106 | HC-105P | HC-105P | KHG | Whole Blood Hemoglobin Determination | 2 | Hemoglobin AC Control Powder | |
6 | 00817869020335 | WBC-HT-111 | WBC-HT-111 | Whole Blood Control Kit containing 8 vials of each: SC-125, SC-126, and DW-101 | Hemotec Whole Blood Control Kit Large | |||
7 | 00817869020212 | HC-118 | HC-118 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin FAS Control | ||
8 | 00817869020151 | HC-108IN | HC-108IN | KHG | Whole Blood Hemoglobin Determination | Hemoglobin G6PDH Intermediate Control | ||
9 | 00817869020311 | SC-125, SC-126, H2O | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Hemotec Whole Blood Control Kit Large | ||
10 | 00817869020274 | SC-127 | SC-127 | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Whole Blood Control Level III | |
11 | 00817869020229 | HC-120 | HC-120 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin AD Control | ||
12 | 00817869020007 | CR-109 | CR-109 | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | .02M Calcium Chloride | |
13 | 00817869020342 | WBC-HT-101 | Whole Blood Control Kit containing 2 vials of each: SC-125, SC-126, and DW-10 | Hemotec Whole Blood Control Kit Small | ||||
14 | 00817869020113 | HC-106 | HC-106 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin F Normal Control | ||
15 | 00817869020069 | HC-102N | HC-102N | KHG | Whole Blood Hemoglobin Determination | Hemoglobin NAFSC Control | ||
16 | 00817869020182 | HC-111 | HC-111 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin A2 Normal Control | ||
17 | 00817869020298 | SC-131EL | SC-131EL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ACE Elevated Control | |
18 | 00817869020236 | HC-127 | HC-127 | KHG | Whole Blood Hemoglobin Determination | HemoglobinAG Philadelphia Control | ||
19 | 00817869020076 | HC-103 | HC-103 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin AF Control | ||
20 | 00817869020137 | HC-108 | HC-108 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin G6PDH Normal Control | ||
21 | 00817869020199 | HC-111EL | HC-111EL | KHG | Whole Blood Hemoglobin Determination | Hemoglobin A2 Elevated Control | ||
22 | 00817869020281 | SC-131 | SC-131 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ACE Normal Control | |
23 | 00817869020250 | SC-125 | SC-125 | JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | Whole Blood Control Level I | |
24 | 00817869020243 | SC-113 | SC-113 | GGC | Control, Plasma, Abnormal | 2 | Animal Plasma Control Level II | |
25 | 00817869020052 | HC-102 | HC-102 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin AFSC Control | ||
26 | 00817869020090 | HC-104 | HC-104 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin AS Control | ||
27 | 00817869020168 | HC-110 | HC-110 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin Total Normal Control | ||
28 | 00817869020083 | HC-105 | HC-105 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin AC Control | ||
29 | 00817869020144 | HC-108DE | HC-108DE | KHG | Whole Blood Hemoglobin Determination | Hemoglobin G6PDH Deficient Control | ||
30 | 00817869020120 | HC-106EL | HC-106EL | KHG | Whole Blood Hemoglobin Determination | Hemoglobin F Abnormal Control | ||
31 | 00817869020205 | HC-117 | HC-117 | KHG | Whole Blood Hemoglobin Determination | Hemoglobin AE Control |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00845275000771 | 100314 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
2 | 00845275000764 | 100309 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
3 | 00845275000665 | 100403 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
4 | 00845275000641 | 100402 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
5 | 00845275000511 | 100304 | Thermo Scientific Pacific Hemostasis® | FISHER DIAGNOSTICS | ||
6 | 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 |
7 | 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 |
8 | 00842768007538 | 10446067 | OQGS35 | Determination of the activated partial thromboplastin time (APTT) in citrated human plasma | Pathromtin® SL | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
9 | 00842768007521 | 10446066 | OQGS29 | Determination of the activated partial thromboplastin time (APTT) in citrated human plasma | Pathromtin® SL | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
10 | 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 |
11 | 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 |
12 | 00817869020014 | CR-121-1 | CR-121-1 | Slide Platelet Aggregation Test Reagent | ANALYTICAL CONTROL SYSTEMS INC | |
13 | 00627944000103 | 10 mL | QuikCoag Calcium Choride 0.02M | BIOMEDICA DIAGNOSTICS INC | ||
14 | 00627944000097 | 4 mL | QuikCoag Calcium Chloride 0.02M | BIOMEDICA DIAGNOSTICS INC | ||
15 | 00627944000059 | 10 mL | QuikCoag APTT-EA | BIOMEDICA DIAGNOSTICS INC | ||
16 | 00627944000042 | 4 mL | QuikCoag APTT-EA | BIOMEDICA DIAGNOSTICS INC | ||
17 | 15391521420517 | T1902 | TriniCLOT™ Calcium Chloride 0.025M | TCOAG IRELAND LIMITED | ||
18 | 15391521420340 | T1206 | TriniCLOT™ Automated aPTT 3 mL | TCOAG IRELAND LIMITED | ||
19 | 15391521420333 | T1205 | TriniCLOT™ Automated aPTT 6 mL | TCOAG IRELAND LIMITED | ||
20 | 13607450003106 | 00310 | STA® - Cephascreen® 10 | DIAGNOSTICA STAGO | ||
21 | 13607450003083 | 00308 | STA® - Cephascreen® 4 | DIAGNOSTICA STAGO | ||
22 | 10711234103029 | J103C | J103C | Citrate APTT Cuvette - 45 test cuvettes/box. | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
23 | M52553890 | 5389 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | ||
24 | M52553880 | 5388 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | ||
25 | M52553870 | 5387 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | ||
26 | M52553860 | 5386 | 0.25 M Calcium Chloride | HELENA LABORATORIES CORPORATION | ||
27 | 08426950915676 | 06260036000 | 06260036000 | GEM TEST APTT CITRATE | GEM TEST APTT CITRATE | INSTRUMENTATION LABORATORY COMPANY |
28 | 08426950433491 | 00020004800 | 00020004800 | HemosIL Silica Clotting Time | HemosIL Silica Clotting Time | INSTRUMENTATION LABORATORY COMPANY |
29 | 08426950087649 | 00020007400 | 00020007400 | HemosIL SynthAFax | HemosIL SynthAFax | INSTRUMENTATION LABORATORY COMPANY |
30 | 08426950087632 | 00020006900 | 00020006900 | HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) | HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) | INSTRUMENTATION LABORATORY COMPANY |
31 | 08426950078937 | 00020006300 | 00020006300 | HemosIL APTT-SP | HemosIL APTT-SP | INSTRUMENTATION LABORATORY COMPANY |
32 | 08426950078920 | 00020006800 | 00020006800 | HemosIL SynthASil | HemosIL SynthASil | INSTRUMENTATION LABORATORY COMPANY |
33 | 08426950023487 | 00019741910 | 00019741910 | HemosIL Calcium Chloride 0.025M (for APTT-SP kit) | HemosIL Calcium Chloride 0.025M (for APTT-SP kit) | INSTRUMENTATION LABORATORY COMPANY |
34 | 05391521420305 | T1202 | TriniCLOT™ aPTT S 3 mL | TCOAG IRELAND LIMITED | ||
35 | 05391521420299 | T1201 | TriniCLOT™ aPTT S 10 mL | TCOAG IRELAND LIMITED | ||
36 | 03607450006001 | 00600 | Staclot® LA | DIAGNOSTICA STAGO | ||
37 | 03607450005943 | 00594 | Staclot® LA 20 | DIAGNOSTICA STAGO |