No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00819704020302 | 3640 | 3951 | 4-MU IDS Reagent Tube, 4.3mLAnalyte Specific Reagent - Analytical and performanc 4-MU IDS Reagent Tube, 4.3mLAnalyte Specific Reagent - Analytical and performance characteristics are not established. | MVU | Reagents, Specific, Analyte | 1 | Baebies 4-MU IDS |
2 | 00819704020258 | 3428 | 3428 | SEEKER™ Personal Computer | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | SEEKER™ |
3 | 00819704020241 | 3145 | 3145 | SEEKER™ Personal Computer | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | SEEKER™ |
4 | 00819704020234 | 3132 | 3132 | SEEKER™ Personal Computer | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | SEEKER™ |
5 | 00819704020227 | 3416 | 3416 | SEEKER™ Quality Control Dried Blood Spot KitContains 5 levels: QC Base Pool, QC SEEKER™ Quality Control Dried Blood Spot KitContains 5 levels: QC Base Pool, QC Low, QC Intermediate, QC Medium, and QC High | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | SEEKER™ |
6 | 00819704020210 | 3369 | 3369 | Quality Control Dried Blood Spot - Intermediate | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Baebies |
7 | 00819704020203 | 3154 | 3154 | SEEKER™ Instrument & AccessoriesThe SEEKER™ Instrument is a quantitative in vitr SEEKER™ Instrument & AccessoriesThe SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes. | KHO | Fluorometer, For Clinical Use | 1 | SEEKER™ |
8 | 00819704020197 | 2188 | 2188 | The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes. | KHO | Fluorometer, For Clinical Use | 1 | SEEKER™ |
9 | 00819704020180 | 2115 | 2115 | SEEKER™ LSD Reagent Kit - IDUA GAA | PQT,PQU,JIX,PPM | Alpha-L-Iduronidase (Idua) Newborn Screening Test System,Alpha-D-Glucosidase (Ga Alpha-L-Iduronidase (Idua) Newborn Screening Test System,Alpha-D-Glucosidase (Gaa) Newborn Screening Test System,Calibrator, Multi-Analyte Mixture,General Purpose Reagent | 1 | SEEKER™ |
10 | 00819704020173 | 2111 | 2111 | The SEEKER™ LSD Reagent Kit - IDUA GAA GBA GLA is intended for quantitative meas The SEEKER™ LSD Reagent Kit - IDUA GAA GBA GLA is intended for quantitative measurement of the activity of α-L-iduronidase, α-D-glucosidase, β-glucocerebrosidase and α-D-galactosidase A from newborn dried blood spot specimens, using the SEEKER Instrument as an aid in screening newborns for Mucopolysaccharidosis Type I, Pompe, Gaucher and Fabry diseases. Reduced activity of these enzymes may be indicative of these lysosomal storage diseases. The enzymes measured using the SEEKER LSD Reagent Kit- IDUA GAA GBA GLA and their associated lysosomal storage diseases are listed below.α-L-iduronidase (IDUA) - Mucopolysaccharidosis Type I (MPS I)α-D-glucosidase (GAA) - Pompeβ-glucocerebrosidase (GBA) - Gaucherα-D-galactosidase (GLA) - Fabry | PQT,PQU,PQV,PQW,JIX,PPM | Alpha-L-Iduronidase (Idua) Newborn Screening Test System,Alpha-D-Glucosidase (Ga Alpha-L-Iduronidase (Idua) Newborn Screening Test System,Alpha-D-Glucosidase (Gaa) Newborn Screening Test System,ß-Glucocerebrosidase (Gba) Newborn Screening Test System,Alpha-D-Galactosidase A (Gla) Newborn Screening Test System,Calibrator, Multi-Analyte Mixture,General Purpose Reagent | 1 | SEEKER™ |
11 | 00819704020166 | 1204 | 1204 | SEEKER™ Stop Buffer | PPM | General Purpose Reagent | 1 | SEEKER™ |
12 | 00819704020159 | 2131 | 2131 | SEEKER™ Calibrant D | JIX | Calibrator, Multi-Analyte Mixture | 2 | SEEKER™ |
13 | 00819704020142 | 2130 | 2130 | SEEKER™ Calibrant C | JIX | Calibrator, Multi-Analyte Mixture | 2 | SEEKER™ |
14 | 00819704020135 | 2129 | 2129 | SEEKER™ Calibrant B | JIX | Calibrator, Multi-Analyte Mixture | 2 | SEEKER™ |
15 | 00819704020111 | 1202 | 1202 | SEEKER™ GLA Reagent (alpha-D-galactosidase) | PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | 2 | SEEKER™ |
16 | 00819704020104 | 1203 | 1203 | SEEKER™ GBA Reagent (ß-Glucocerebrosidase) | PQV | ß-Glucocerebrosidase (Gba) Newborn Screening Test System | 2 | SEEKER™ |
17 | 00819704020098 | 1200 | 1200 | SEEKER™ IDUA Reagent (alpha-L-iduronidase) | PQT | Alpha-L-Iduronidase (Idua) Newborn Screening Test System | 2 | SEEKER™ |
18 | 00819704020081 | 1201 | 1201 | SEEKER™ GAA Reagent (alpha-D-glucosidase) | PQU | Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | 2 | SEEKER™ |
19 | 00819704020067 | 0977 | 0977 | Quality Control Dried Blood Spot - High | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Baebies |
20 | 00819704020050 | 0976 | 0976 | Quality Control Dried Blood Spot - Medium | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Baebies |
21 | 00819704020043 | 0975 | 0975 | Quality Control Dried Blood Spot - Low | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Baebies |
22 | 00819704020036 | 0974 | 0974 | Quality Control Dried Blood Spot - Base Pool | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Baebies |
23 | 00819704020029 | 1305 | 3141 | SEEKER™ disposable Cartridge | PPM | General Purpose Reagent | SEEKER™ | |
24 | 00819704020012 | 0305 | 3140 | SEEKER™ Extraction Buffer | PPM | General Purpose Reagent | SEEKER™ | |
25 | 00819704020005 | 0802 | 2573 | SEEKER™ Filler Fluid | PPM | General Purpose Reagent | SEEKER™ | |
26 | 00819704020326 | 3673 | 3953 | Baebies C-Stop SolutionGeneral Purpose Reagent, For Laboratory Use. | PPM | General Purpose Reagent | 1 | Baebies C-Stop Solution |
27 | 00819704020319 | 3952 | 3952 | 4-MU Dilution SetGeneral Purpose Reagent, For Laboratory Use. | PPM | General Purpose Reagent | 1 | Baebies 4-MU Dilution Set |
28 | 00819704020272 | 2105 | 3725 | Baebies Stop SolutionGeneral Purpose Reagent, For Laboratory Use. | PPM | General Purpose Reagent | 1 | Baebies Stop Solution |
29 | 00819704020265 | 2103 | 2103 | 6-HMU GALC Substrate.Analyte Specific Reagent - Analytical and performance chara 6-HMU GALC Substrate.Analyte Specific Reagent - Analytical and performance characteristics are not established. | MVU | Reagents, Specific, Analyte | Baebies 6-HMU GALC | |
30 | 00819704020296 | 2114 | 3726 | Baebies Extraction SolutionGeneral Purpose Reagent, For Laboratory Use | PPM | General Purpose Reagent | 1 | Baebies Extraction Solution |
31 | 00819704020289 | 2110 | 2110 | 6-HMU Dilution SetGeneral Purpose Reagent, For Laboratory Use. | PPM | General Purpose Reagent | Baebies 6-HMU Dilution Set |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00884883001268 | 100007 | CEDIA Core TDM Multi-Calibrators | MICROGENICS CORPORATION | ||
2 | 00884883001213 | 100001 | CEDIA Cardiac TDM Multi-Calibrators | MICROGENICS CORPORATION | ||
3 | 00857969006389 | SA1029 | SA1029 | CAL A | Alfa Wassermann | ALFA WASSERMANN, INC. |
4 | 00857969006198 | S2-85 | S2-85 | Urine Standard | Alfa Wassermann | ALFA WASSERMANN, INC. |
5 | 00857969006181 | S1-33 | S1-33 | GemCal Reference Serum | Alfa Wassermann | ALFA WASSERMANN, INC. |
6 | 00853366007783 | 23-202 | Calibrator 2 for Tokyo Boeki BiOLiS 50i Series Electrolyte Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
7 | 00853366007776 | 19-007D | Cal Pack (Snap Pack) for Medica EasyLyte Expand Electrolyte Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
8 | 00853366007721 | 13-002 | Urine Standard for I.L. 943 | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
9 | 00853366007714 | 13-020 | Rinse Solution for I.L. 943 | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
10 | 00853366007707 | 13-011 | Cesium Internal Standard for I.L. 943 | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
11 | 00853366007691 | 13-005 | Flame Standard 140/5 for I.L. 943 | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
12 | 00853366007615 | 19-007S | 19-007S | Universal Cal Pack (Snap Pack) for Menarini SpotLyte Series Electrolyte Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
13 | 00853366007608 | 19-007 | 19-007 | Universal Cal Pack (Snap Pack) for Medica EasyLyte Series Electrolyte Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
14 | 00853366007592 | 19-006IL | Universal Cal Pack (Snap Pack) for I.L. ILyte Series Electrolyte Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
15 | 00853366007585 | 19-006 | ISE Cal Pack (Snap Pack) for Medica Na/K/Ca/pH EasyLyte Electrolyte Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
16 | 00853366007578 | 19-005 | Universal Cal Pack (Open) for Medica EasyLyte Series Electrolyte Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
17 | 00853366007486 | 4-180 | ISE Reagent Pack for Roche / AVL 9180 & 9181 Series Electrolyte Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | |
18 | 00853366007462 | 4-130 | 4-130 | ISE Reagent Pack for Roche / AVL 9120 & 9130 Series Electrolyte Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
19 | 00853366007455 | PH7001 | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
20 | 00853366007448 | PH7000 | Multi-Analyte Chemistry Calibrator (1-Point) | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
21 | 00853366007370 | 23-102 | 23-102 | Calibrator 2 for Tokyo Boeki BiOLiS Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
22 | 00853366007363 | 23-101 | 23-101 | Calibrator 1 for Tokyo Boeki BiOLiS Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
23 | 00853366007295 | 16-219 | 16-219 | Na / Cl Calibrator for Roche / Hitachi Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
24 | 00853366007271 | 16-215 | ISE Compensator for Roche / Hitachi Chemistry Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
25 | 00853366007226 | 16-206 | 16-206 | ISE Standard High for Roche / Hitachi Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
26 | 00853366007219 | 16-205 | 16-205 | ISE Standard Low for Roche / Hitachi Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
27 | 00853366007196 | 16-203 | 16-203 | ISE 1N KCL Sol for Roche / Hitachi 700 & 900 Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
28 | 00853366007172 | 16-202 | 16-202 | ISE Internal Ref Sol for Roche / Hitachi 700 & 900 Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
29 | 00853366007141 | 16-200 | 16-200 | ISE Diluent for Roche / Hitachi 704, 902, and P800 Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
30 | 00853366007066 | 21-106 | ISE Low/High Urine Standard for Olympus AU Series Chemistry Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. | |
31 | 00853366007042 | 21-104 | ISE Low Serum Standard for Olympus AU Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | |
32 | 00853366007028 | 21-102 | ISE Mid Standard Solution for Olympus AU Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | |
33 | 00853366007011 | 21-101 | ISE Buffer Solution for Olympus AU Series Chemistry Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | |
34 | 00852676007780 | 3-602 | Calibrator 2 for Perlong Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | |
35 | 00852676007773 | 3-601 | Cal 1 for NuLyte Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | |
36 | 00852676007766 | 3-702 | 3-702 | Calibrator 2 for NuLyte Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. |
37 | 00852676007759 | 3-701 | 3-701 | Calibrator 1 for NuLyte Systems | PHOENIX DIAGNOSTICS, INC. | PHOENIX DIAGNOSTICS, INC. |
38 | 00852676007056 | 3-223 | 3-223 | Buffer Pack 348 for Siemens / Bayer Blood Gas Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
39 | 00852676007049 | 3-221 | Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | |
40 | 00852676007025 | 3-211 | 3-211 | Slope Solution 238 for Bayer / Ciba-Corning Blood Gas Systems | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. |
41 | 00852553007377 | 9070 | Calibrator / Calibration Verifier | Ammonia Standard Kit | VERICHEM LABORATORIES, INC. | |
42 | 00852553007360 | 9217 | Calibrator / Calibration Verifier | Carbon Dioxide Standard | VERICHEM LABORATORIES, INC. | |
43 | 00852553007353 | 9060 | Calibrator / Calibration Verifier | Iron Standard Kit | VERICHEM LABORATORIES, INC. | |
44 | 00852553007292 | 9820 | Calibration Verifier | Chemistry 3 Install Verifier Kit | VERICHEM LABORATORIES, INC. | |
45 | 00852553007278 | 9216 | Calibrator / Calibration Verifier | Carbon Dioxide Standard, Level F | VERICHEM LABORATORIES, INC. | |
46 | 00852553007261 | 9043 | Calibrator /Calibration Verifier | Ammonia / Iron Standard, Level C | VERICHEM LABORATORIES, INC. | |
47 | 00852553007254 | 9250 | Calibrator / Calibration Verifier | Serum ISE Verifier Kit | VERICHEM LABORATORIES, INC. | |
48 | 00852553007216 | 9046 | Calbrator / Calibration Verifier | Ammonia / Iron Standard, Level F | VERICHEM LABORATORIES, INC. | |
49 | 00852553007209 | 9510 | Calibrator / Calibration Verifier | Chemistry Reference Kit | VERICHEM LABORATORIES, INC. | |
50 | 00852553007193 | 9480 | Calibrator / Calibration Verifier | MIcroprotein Standard Kit | VERICHEM LABORATORIES, INC. |