No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04987562433698 | CN383000 | UF-CALIBRATOR | JIW | Calibrator, surrogate | UF-CALIBRATOR | ||
2 | 14987562460332 | 213528 | XN CAL 5X3.0ML | KRX | CALIBRATOR FOR CELL INDICES | 2 | XN CAL | |
3 | 04987562444779 | CJ445012 | Fully Automated Urine Particle Digital Imaging Device UD-10 | JOY | DEVICE, AUTOMATED CELL-LOCATING | 2 | Fully Automated Urine Particle Digital Imaging Device UD-10 | |
4 | 04987562434572 | BD634545 | Automated Hematology Analyzer XN-L series XN-550 | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN-L series XN-550 | |
5 | 04987562425716 | CK978289 | Automated Blood Coagulation Analyzer CA-660 | GKP | INSTRUMENT, COAGULATION, AUTOMATED | 2 | Automated Blood Coagulation Analyzer CA-600 series CA-660 | |
6 | 04987562425426 | BY990757 | CS-5100 COMPLETE | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Automated Blood Coagulation Analyzer CS-5100 | |
7 | 04987562408535 | 06404310 | UF ll CALIBRATOR | JIW | CALIBRATOR, SURROGATE | UF ll CALIBRATOR | ||
8 | 14987562460387 | 218981 | Range Check X lll 24X3.0ML WBC/RBC/PLT | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | RANGE CHECK X lll | |
9 | 14987562508003 | CC118360 | Platelet CHECK | Platelet CHECK Level 2-16x3.0ML | GJP | Control, Platelet | 2 | Platelet CHECK |
10 | 14987562507990 | CN464998 | Platelet CHECK | Platelet CHECK Level 1-16x3.0ML | GJP | Control, Platelet | 2 | Platelet CHECK |
11 | 04987562440139 | BN344411 | Fully Automated Urine Particle Analyzer UF-5000 | LKM | COUNTER, URINE PARTICLE | 2 | Fully Automated Urine Particle Analyzer UF-5000 | |
12 | 04987562434534 | AW618382 | Automated Hematology Analyzer XN-L series XN-350 | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN-L series XN-350 | |
13 | 04987562429219 | AR408878 | Automated Hematology Analyzer XP-300 | GKZ,GKL | Counter, differential cell,COUNTER, CELL, AUTOMATED (PARTICLE COUNTER) | 2 | Automated Hematology Analyzer XP series XP-300 | |
14 | 04987562412860 | BB046392 | XS-1000iC Complete | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XS series XS-1000iC | |
15 | 14987562460578 | 199-5002-0 | E-Check (XS) 5X1.5MLX2 Normal/High | GLQ,JPK | MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES,MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | e-CHECK(XS) | |
16 | 14987562460561 | 199-5001-0 | E-Check (XS) 5X1.5MLX1 Low | JPK,GLQ | MIXTURE, HEMATOLOGY QUALITY CONTROL,MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 2 | e-CHECK(XS) | |
17 | 04987562434527 | CX851950 | Automated Hematology Analyzer XN-L series XN-330 | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN-L series XN-330 | |
18 | 04987562433735 | BV981798 | CS-2500 COMPLETE | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Automated Blood Coagulation Analyzer CS-2500 | |
19 | 14987562460356 | 213537 | XN CAL PF 5X3.0ML | KRX | CALIBRATOR FOR CELL INDICES | 2 | XN CAL PF | |
20 | 04987562424214 | AP795756 | XN-10 Complete | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN series XN-10 | |
21 | 14987562460349 | 213536 | XN CAL PF 1X3.0ML | KRX | CALIBRATOR FOR CELL INDICES | 2 | XN CAL PF | |
22 | 04987562434541 | CL032175 | Automated Hematology Analyzer XN-L series XN-430 | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN-L series XN-430 | |
23 | 04987562432615 | CS297931 | XN-11 Complete | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN series XN-11 | |
24 | 04987562424221 | AE797961 | Automated Hematology Analyzer XN series XN-20 | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN series XN-20 | |
25 | 04987562408542 | 05366719 | Sysmex UF-1000i™ Automated Urine Particle Analyzer | LKM | COUNTER, URINE PARTICLE | 2 | Fully Automated Urine Particle Analyzer UF-1000i | |
26 | 04987562406807 | 05342311 | Sysmex XS-1000i™ Automated Hematology Analyzer | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XS series XS-1000i | |
27 | 14987562460615 | 200-4004-1 | plt-CHECK Level 2- 12X4.5ML | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | plt-CHECK | |
28 | 14987562460608 | 200-4004-0 | plt-CHECK Level 1-12X4.5ML | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | plt-CHECK | |
29 | 14987562460592 | 110-4008-0 | X-Cal FSR Kit (5X4.6ML) | KRX | CALIBRATOR FOR CELL INDICES | 2 | X-CAL Calibrator | |
30 | 14987562460585 | 110-4009-0 | X-Cal Hematology Calibrator (4.6ML) | KRX | CALIBRATOR FOR CELL INDICES | 2 | X-CAL Calibrator | |
31 | 14987562460394 | AS747750 | XN-L CHECK | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | XN-L CHECK | |
32 | 14987562460288 | 199-4004-1 | E-Check 4X4.5MLX3 Low/Normal/High | JPK,GLQ | MIXTURE, HEMATOLOGY QUALITY CONTROL,MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 2 | e-CHECK | |
33 | 04987562434565 | BQ391107 | Automated Hematology Analyzer XN-L series XN-530 | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN-L series XN-530 | |
34 | 04987562490110 | CT129514 | Automated Hematology Analyzer XW-100 | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XW-100 | |
35 | 04987562434558 | BM392756 | Automated Hematology Analyzer XN-L series XN-450 | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XN-L series XN-450 | |
36 | 04987562402021 | 02318618 | pocH-100i (US) | GKZ,GKL | Counter, differential cell,COUNTER, CELL, AUTOMATED (PARTICLE COUNTER) | 2 | Automated Hematology Analyzer pocH-100i | |
37 | 14987562460325 | 213527 | XN CAL 1X3.0ML | KRX | CALIBRATOR FOR CELL INDICES | 2 | XN CAL | |
38 | 14987562460318 | 213516 | XN CHECK BF 6X3.0ML L 1,2 | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | XN CHECK BF | |
39 | 14987562460370 | 217685 | SCS-1000 Universal Calibrator 1X2ML | KSA | CALIBRATOR FOR RED-CELL AND WHITE-CELL COUNTING | 2 | SCS-1000 Calibrator | |
40 | 14987562460257 | 130-4003-0 | Range Check X ll | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | RANGE CHECK X ll | |
41 | 04987562404087 | 03309313 | Automated Hematology Analyzer XE-2100D | GKZ | Counter, differential cell | 2 | Automated Hematology Analyzer XE-2100D | |
42 | 14987562502766 | NSH-100G | BV166979 | XN CHECK 8 x 3.0mL, Level 3 | JPK | Mixture, Hematology Quality Control | 2 | XN CHECK |
43 | 14987562502759 | NSN-100G | CV649926 | XN CHECK 8 x 3.0mL, Level 2 | JPK | Mixture, Hematology Quality Control | 2 | XN CHECK |
44 | 14987562502742 | NSL-100G | AF640985 | XN CHECK 8 x 3.0mL, Level 1 | JPK | Mixture, Hematology Quality Control | 2 | XN CHECK |
45 | 14987562490216 | BP935764 | XW QC CHECK | JPK | Mixture, hematology quality control | 2 | XW QC CHECK | |
46 | 14987562461780 | BG234784 | WRP CHECK | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | WRP CHECK | |
47 | 14987562460295 | 201-6001-0 | E-Check (XE) 4X4.5MLX3 Levels | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | e-CHECK(XE) | |
48 | 14987562460264 | 140-3004-0 | EightCheck-3WP X-tra 4X2MLX3 Lo/Norm/Hi | JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL | 2 | EIGHTCHECK-3WP | |
49 | 04987562425686 | BR142626 | Automated Blood Coagulation Analyzer CA-620 | JPA,GKP | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES,INSTRUMENT, COAGULATION, AUTOMATED | 2 | Automated Blood Coagulation Analyzer CA-600 series CA-620 | |
50 | 04987562409471 | 06372511 | CS-2100i COMPLETE | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Automated Blood Coagulation Analyzer CS-2100i |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00812137011299 | 12 x 4.5mL | 501-608 | For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product. | Boule Con-Diff Tri-Level | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
2 | 00812137010414 | Tri-Pack 6x4.5 mL | 502-066 | For in vitro diagnostic use as a control to monitor the performance of multi-par For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean. | CDS 3PD Hematology Control | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
3 | 00812137010247 | Tri-Pack 6x3.0mL | 502-004 | For in vitro diagnostic use as a control to monitor the performance of multi-par For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean. | CDS™ 3-PD Hematology Control | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
4 | 00812137010230 | 9 x 4.5mL | 501-607 | For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product. | Boule Con-Diff Tri-Level | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
5 | 00812137010216 | 6 x 4.5mL | 501-605 | For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product. | Boule Con-Diff Tri-Level | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
6 | 00811727014566 | H7546-CTL | H7546-CTL | Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls con Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human blood based solutions. It is intended to simulate human patient whole blood samples for the purpose of monitoring the precision of laboratory testing procedures for the following assays: HbA1c. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. Size: 4 x 0.5 mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
7 | 00811727011497 | H7506-6 | H7506-6 | Reagent intended for use as human hemoglobin controls for the cyanmethemoglobin Reagent intended for use as human hemoglobin controls for the cyanmethemoglobin hemoglobin procedure3 x 2ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
8 | 00657498000168 | 503000 | 503000 | A bi-level reference control intended for use on STAT-Site® and HemoSite® hemogl A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System. | STAT-Site Hgb Controls | STANBIO LABORATORY, L.P. |
9 | 00630414600840 | 11170854 | 11170854 | ADVIA® 560 Control | ADVIA® 560 Control | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414600833 | 11170853 | 11170853 | ADVIA®360 Control | ADVIA® 360 Control | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00630414472539 | 10314243 | T03-4485-01 | ADVIA®120/2120/2120i TESTpoint™ CSF Control Kit | ADVIA® 120/2120/2120i TESTpoint CSF Control Kit | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
12 | 00630414224442 | 10312295 | T03-3691-54 | ADVIA®120/2120/2120i TESTpoint™ Retic High Control | ADVIA® 120/2120/2120i TESTpoint Retic High Control | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
13 | 00630414224428 | 10312293 | T03-3690-54 | ADVIA®120/2120/2120i TESTpoint™ Retic Control Low | ADVIA® 120/2120/2120i TESTpoint Retic Low Control | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
14 | 00385480539852 | 16 | 53985 | Nova 16/16+ Analyzer w/ Ptr / Dilutor | Nova | NOVA BIOMEDICAL CORPORATION |
15 | 00385480498470 | PHOX/BASIC/BIOPHOX | 49847 | Stat Profile pHOx/Basic/BiopHOx W/R Pump Tubing Kit | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
16 | 00385480498463 | PHOX/BASIC/BIOPHOX | 49846 | Stat Profile pHOx/Basic/BiopHOx W/R Pump Tubing Assembly | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
17 | 00385480407298 | CCX | 40729 | STAT PROFILE CRITICAL CARE EXPRESS CAPILLARY TUBE 115 uL WITH Na HEPARIN | Stat Profile | NOVA BIOMEDICAL CORPORATION |
18 | 00385480407236 | CCX | 40723 | STAT PROFILE CRITICAL CARE EXPRESS CAPILLARY TUBE 150 uL WITH Na HEPARIN | Stat Profile | NOVA BIOMEDICAL CORPORATION |
19 | 00385480407229 | CCX | 40722 | STAT PROFILE CRITICAL CARE EXPRESS CAPILLARY TUBE 230 uL WITH Na HEPARIN | Stat Profile | NOVA BIOMEDICAL CORPORATION |
20 | 00385480407212 | CCX | 40721 | STAT PROFILE CRITICAL CARE EXPRESS MAGNETS FOR CAPILLARY TUBES 10 PER VIAL | Stat Profile | NOVA BIOMEDICAL CORPORATION |
21 | 00385480381857 | CCX CO-OX | 38185 | STAT PROFILE CRITICAL CARE XPRESS CO-OXIMETER CUVETTE WASHER KIT | Stat Profile | NOVA BIOMEDICAL CORPORATION |
22 | 00385480380256 | PHOX PLUS C | 38025 | Remanufactured Stat Profile pHOx Plus C Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
23 | 00385480379595 | CCX | 37959 | Stat Profile CCX Reference Sensor | Stat Profile | NOVA BIOMEDICAL CORPORATION |
24 | 00385480379380 | CCX | 37938 | STAT PROFILE CCX HEMOLYZER TUBING HARNESS | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
25 | 00385480375627 | CCX | 37562 | Remanufactured Stat Profile Critical Care Xpress Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
26 | 00385480375559 | CCX CO OX | 37555 | Remanufactured Stat Profile Critical Care Xpress CO-Oximeter Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
27 | 00385480374132 | CCX CO OX | 37413 | Stat Profile Critical Care Express CO-Oximeter Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
28 | 00385480373432 | pHOx Plus C | 37343 | STAT PROFILE pHOx PLUS C SENSOR MODULE | Stat Profile | NOVA BIOMEDICAL CORPORATION |
29 | 00385480367943 | CCX | 36794 | STAT PROFILE CRITICAL CARE XPRESS CONTROL FLUSH FIXTURE | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
30 | 00385480367868 | CCX | 36786 | STAT PROFILE CRITICAL CARE XPRESS FLUSH FIXTURE | Stat Profile | NOVA BIOMEDICAL CORPORATION |
31 | 00385480364614 | CCX | 36461 | TUBING ASSEMBLY L4, L5, L6 STP CCX | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
32 | 00385480364591 | CCX | 36459 | TUBING ASSEMBLIES L1, L2, L3 STP CCX | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
33 | 00385480364577 | CCX | 36457 | STAT PROFILE CCX W/R TUBING HARNESS | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
34 | 00385480364553 | CCX CO-OX | 36455 | CO-OX TUBING ASSY STP CCX | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
35 | 00385480364539 | CCX | 36453 | TUBING ASSEMBLY C1, C2, C3 STP CCX | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
36 | 00385480362597 | CCX | 36259 | STAT PROFILE CCX S LINE REPLACEMENT | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
37 | 00385480359429 | CCX | 35942 | Stat Profile Critical Care Express Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
38 | 00385480355407 | PHOX BASIC | 35540 | Remanufactured Stat Profile Phox Basic Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
39 | 00385480355360 | PHOX PLUS C | 35536 | Stat Profile pHOx Plus C Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
40 | 00385480353496 | PHOX BASIC | 35349 | Stat Profile PHOX BASIC Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
41 | 00385480347174 | PHOX PLUS L | 34717 | Remanufactured Stat Profile pHOx Plus L Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
42 | 00385480346559 | PHOX | 34655 | STAT PROFILE pHOx REFERENCE TUBING REPLACEMENT, INTERNAL | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
43 | 00385480346474 | PHOX | 34647 | WASTE TUBE ASSEMBLY, pHOx (REPLACEMENT), INTERNAL | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
44 | 00385480346436 | PHOX PLUS/C | 34643 | STAT PROFILE pHOx PLUS/C PROBE | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
45 | 00385480340816 | PHOX PLUS L | 34081 | Stat Profile pHOx Plus L Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
46 | 00385480248198 | CCX/PHOX/BASIC/PLUS/L/C | 24819 | Stat Profile CCX Stat Profile pHOx/Basic/Plus/L/C/M Control Flush Fixture | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
47 | 00385480243278 | PHOX/BASIC/PLUS/L/C | 24327 | STAT PROFILE pHOx/BASIC/PLUS/L/C FLUSH FIXTURE | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
48 | 00385480239622 | PHOX | 23962 | Remanufactured Stat Profile pHOx Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
49 | 00385480225076 | pHOx/BASIC/PLUS/L/C | 22507 | STAT PROFILE pHOx/BASIC/PLUS/L/C SENSOR | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
50 | 00385480215206 | pHOx | 21520 | STAT PROFILE pHOx REFERENCE SENSOR | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |