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 | 00819704020128 | 2128 | 2128 | SEEKER™ Calibrant A | JIX | Calibrator, Multi-Analyte Mixture | 2 | SEEKER™ |
16 | 00819704020111 | 1202 | 1202 | SEEKER™ GLA Reagent (alpha-D-galactosidase) | PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | 2 | SEEKER™ |
17 | 00819704020104 | 1203 | 1203 | SEEKER™ GBA Reagent (ß-Glucocerebrosidase) | PQV | ß-Glucocerebrosidase (Gba) Newborn Screening Test System | 2 | SEEKER™ |
18 | 00819704020098 | 1200 | 1200 | SEEKER™ IDUA Reagent (alpha-L-iduronidase) | PQT | Alpha-L-Iduronidase (Idua) Newborn Screening Test System | 2 | SEEKER™ |
19 | 00819704020081 | 1201 | 1201 | SEEKER™ GAA Reagent (alpha-D-glucosidase) | PQU | Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | 2 | SEEKER™ |
20 | 00819704020067 | 0977 | 0977 | Quality Control Dried Blood Spot - High | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Baebies |
21 | 00819704020050 | 0976 | 0976 | Quality Control Dried Blood Spot - Medium | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Baebies |
22 | 00819704020043 | 0975 | 0975 | Quality Control Dried Blood Spot - Low | 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 | 07070060014647 | 1116973 | 1116973 | ACR Controls for use with theAfinion ACR test. Contents: 1 Control C I, 1 Contro ACR Controls for use with theAfinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert. | Afinion ACR Control | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
2 | 05700699460608 | 946-060 | 946-060 | Sensor cassette SC90 1200 BG, LYT, MET, OXI + QC for ABL90. 1200 tests. Blood ga Sensor cassette SC90 1200 BG, LYT, MET, OXI + QC for ABL90. 1200 tests. Blood gas, Electrolytes, Metabolites, CO-OX including Auto QC | ABL90 Sensor Cassette pack | RADIOMETER MEDICAL APS |
3 | 05700699460134 | 946-013 | 946-013 | Sensor cassette SC90 600 BG, LYT, OXI + QC for ABL90, 600 tests. Blood gas, Ele Sensor cassette SC90 600 BG, LYT, OXI + QC for ABL90, 600 tests. Blood gas, Electrolytes, CO-OX. Including Auto QC | ABL90 Sensor Cassette pack | RADIOMETER MEDICAL APS |
4 | 05700699460103 | 946-010 | 946-010 | Sensor cassette SC90 100 BG, LYT, MET, OXI +QC Blood gas, lytes, metabolites, CO Sensor cassette SC90 100 BG, LYT, MET, OXI +QC Blood gas, lytes, metabolites, CO-OX including auto QC. | ABL90 Sensor Cassette pack | RADIOMETER MEDICAL APS |
5 | 05700699460097 | 946-009 | 946-009 | Sensor cassette SC90 900 BG, LYT, MET, OXI + QC for ABL90. 900 tests. Blood gas, Sensor cassette SC90 900 BG, LYT, MET, OXI + QC for ABL90. 900 tests. Blood gas, Electrolytes , Metabolites, CO-OX including Auto QC. | ABL90 Sensor Cassette pack | RADIOMETER MEDICAL APS |
6 | 05700699460080 | 946-008 | 946-008 | Sensor cassette SC90 600 BG, LYT, MET, OXI + QC for ABL90. 600 tests. Blood gas, Sensor cassette SC90 600 BG, LYT, MET, OXI + QC for ABL90. 600 tests. Blood gas, Electrolytes, Metabolites, CO-OX, Including Auto QC | ABL90 Sensor Cassette pack | RADIOMETER MEDICAL APS |
7 | 05700699460059 | 946-005 | 946-005 | Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 300 tests, Blood gas. Sensor cassette SC90 300BG, LYT, MET, OXI + QC for ABL90. 300 tests, Blood gas. Electrolytes, Metabolites, CO-OX, Including Auto QC | ABL90 Sensor Cassette pack | RADIOMETER MEDICAL APS |
8 | 05700699458438 | 945-843 | 945-843 | SC80 200/60 for FLEX, CO-OX,OSM version | ABL80 SC80 | RADIOMETER MEDICAL APS |
9 | 05700699458063 | 945-806 | 945-806 | SC80 600/60 CO-OX for OSM SW | ABL80 SC80 | RADIOMETER MEDICAL APS |
10 | 05700699457738 | 945-773 | 945-773 | SC80 25/30 BG/Hct, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
11 | 05700699457714 | 945-771 | 945-771 | SC80 25/30 Full, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
12 | 05700699457707 | 945-770 | 945-770 | SC80 25/30 BG/Hct, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
13 | 05700699457691 | 945-769 | 945-769 | SC80 25/30 Full, no GLU, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
14 | 05700699457684 | 945-768 | 945-768 | SC80 25/30 Full, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
15 | 05700699457349 | 945-734 | 945-734 | SC80 300/30 BG/OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
16 | 05700699457332 | 945-733 | 945-733 | SC80 200/30 BG/OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
17 | 05700699457325 | 945-732 | 945-732 | SC80 100/30 BG/OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
18 | 05700699457318 | 945-731 | 945-731 | SC80 50/30 BG/OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
19 | 05700699457301 | 945-730 | 945-730 | SC80 25/30 BG/OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
20 | 05700699457295 | 945-729 | 945-729 | SC80 300/15 Full-OX, noGlu, noQC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
21 | 05700699457288 | 945-728 | 945-728 | SC80 300/30 Full-OX, noGlu, noQC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
22 | 05700699457271 | 945-727 | 945-727 | SC80 200/30 Full-OX, noGlu, noQC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
23 | 05700699457264 | 945-726 | 945-726 | SC80 100/30 Full-OX, noGlu, noQC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
24 | 05700699457257 | 945-725 | 945-725 | SC80 50/30 Full-OX, noGlu, noQC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
25 | 05700699457240 | 945-724 | 945-724 | SC80 25/30 Full-OX noGlu, noQC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
26 | 05700699457226 | 945-722 | 945-722 | SC80 300/30 Full-OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
27 | 05700699457219 | 945-721 | 945-721 | SC80 200/30 Full-OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
28 | 05700699457202 | 945-720 | 945-720 | SC80 100/30 Full-OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
29 | 05700699457196 | 945-719 | 945-719 | SC80 50/30 Full-OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
30 | 05700699457189 | 945-718 | 945-718 | SC80 25/30 Full-OX, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
31 | 05700699457172 | 945-717 | 945-717 | SC80 300/15 BG/OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
32 | 05700699457165 | 945-716 | 945-716 | SC80 300/30 BG/OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
33 | 05700699457158 | 945-715 | 945-715 | SC80 200/30 BG/OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
34 | 05700699457141 | 945-714 | 945-714 | SC80 100/30 BG/OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
35 | 05700699457134 | 945-713 | 945-713 | SC80 50/30 BG/OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
36 | 05700699457127 | 945-712 | 945-712 | SC80 25/30 BG/OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
37 | 05700699457110 | 945-711 | 945-711 | SC80 300/15 Full-OX noGlu, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
38 | 05700699457103 | 945-710 | 945-710 | SC80 300/30 Full-OX noGlu, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
39 | 05700699457097 | 945-709 | 945-709 | SC80 200/30 Full-OX noGlu, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
40 | 05700699457080 | 945-708 | 945-708 | SC80 100/30 Full-OX noGlu, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
41 | 05700699457073 | 945-707 | 945-707 | SC80 50/30 Full-OX noGlu, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
42 | 05700699457066 | 945-706 | 945-706 | SC80 25/30 Full-OX noGlu, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
43 | 05700699457059 | 945-705 | 945-705 | SC80 300/15 Full-OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
44 | 05700699457042 | 945-704 | 945-704 | SC80 300/30 Full-OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
45 | 05700699457035 | 945-703 | 945-703 | SC80 200/30 Full-OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
46 | 05700699457028 | 945-702 | 945-702 | SC80 100/30 Full-OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
47 | 05700699457011 | 945-701 | 945-701 | SC80 50/30 Full-OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
48 | 05700699457004 | 945-700 | 945-700 | SC80 25/30 Full-OX, QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
49 | 05700699456939 | 945-693 | 945-693 | SC80 300/30 BG/Hct, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |
50 | 05700699456915 | 945-691 | 945-691 | SC80 100/30 BG/Hct, no QC3 | ABL80 SC80 | RADIOMETER MEDICAL APS |