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 | 00819704020036 | 0974 | 0974 | Quality Control Dried Blood Spot - Base Pool | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Baebies |
24 | 00819704020029 | 1305 | 3141 | SEEKER™ disposable Cartridge | PPM | General Purpose Reagent | SEEKER™ | |
25 | 00819704020012 | 0305 | 3140 | SEEKER™ Extraction Buffer | PPM | General Purpose Reagent | SEEKER™ | |
26 | 00819704020005 | 0802 | 2573 | SEEKER™ Filler Fluid | PPM | General Purpose Reagent | SEEKER™ | |
27 | 00819704020326 | 3673 | 3953 | Baebies C-Stop SolutionGeneral Purpose Reagent, For Laboratory Use. | PPM | General Purpose Reagent | 1 | Baebies C-Stop Solution |
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 | 00819704020326 | 3673 | 3953 | Baebies C-Stop SolutionGeneral Purpose Reagent, For Laboratory Use. | Baebies C-Stop Solution | BAEBIES, INC. |
2 | 00819704020319 | 3952 | 3952 | 4-MU Dilution SetGeneral Purpose Reagent, For Laboratory Use. | Baebies 4-MU Dilution Set | BAEBIES, INC. |
3 | 00819704020296 | 2114 | 3726 | Baebies Extraction SolutionGeneral Purpose Reagent, For Laboratory Use | Baebies Extraction Solution | BAEBIES, INC. |
4 | 00819704020289 | 2110 | 2110 | 6-HMU Dilution SetGeneral Purpose Reagent, For Laboratory Use. | Baebies 6-HMU Dilution Set | BAEBIES, INC. |
5 | 00819704020272 | 2105 | 3725 | Baebies Stop SolutionGeneral Purpose Reagent, For Laboratory Use. | Baebies Stop Solution | BAEBIES, INC. |
6 | 00819704020180 | 2115 | 2115 | SEEKER™ LSD Reagent Kit - IDUA GAA | SEEKER™ | BAEBIES, INC. |
7 | 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 | SEEKER™ | BAEBIES, INC. |
8 | 00819704020166 | 1204 | 1204 | SEEKER™ Stop Buffer | SEEKER™ | BAEBIES, INC. |
9 | 00819704020029 | 1305 | 3141 | SEEKER™ disposable Cartridge | SEEKER™ | BAEBIES, INC. |
10 | 00819704020012 | 0305 | 3140 | SEEKER™ Extraction Buffer | SEEKER™ | BAEBIES, INC. |
11 | 00819704020005 | 0802 | 2573 | SEEKER™ Filler Fluid | SEEKER™ | BAEBIES, INC. |
12 | 00817302024302 | CC446 | CC446 | SPECIFIC GRAVITY REAGENT | CAROLINA LIQUID CHEMISTRIES CORP.® SPECIFIC GRAVITY REAGENT REAGENT KIT CC446 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
13 | 00816387021145 | TBRB30 | MycoDDR Resuspension Buffer C | IMMY | IMMUNO-MYCOLOGICS, INC. | |
14 | 00816387021121 | TBPN67-500 | MycoDDR Neutralization Buffer B | IMMY | IMMUNO-MYCOLOGICS, INC. | |
15 | 00816387021107 | TBPN67 | MycoDDR Neutralization Buffer B | IMMY | IMMUNO-MYCOLOGICS, INC. | |
16 | 00816387021084 | TBP300 | NALC Powder | IMMY | IMMUNO-MYCOLOGICS, INC. | |
17 | 00816387021060 | NAOH30 | 3.0% NaOH Reagent A | IMMY | IMMUNO-MYCOLOGICS, INC. | |
18 | 00816387021046 | NAOH25 | 2.5% NaOH Reagent A | IMMY | IMMUNO-MYCOLOGICS, INC. | |
19 | 00816387020995 | DDR012-3.0 | MycoDDR 3.0% NaOH Reagent Kit | IMMY | IMMUNO-MYCOLOGICS, INC. | |
20 | 00816387020988 | DDR012-2.5 | MycoDDR 2.5% NaOH Reagent Kit | IMMY | IMMUNO-MYCOLOGICS, INC. | |
21 | 00816387020964 | MPB075-3.0 | MycoDDR Prep Blue 3.0% | IMMY | IMMUNO-MYCOLOGICS, INC. | |
22 | 00816387020940 | MPB075-2.5 | MycoDDR Prep Blue - 2.5% | IMMY | IMMUNO-MYCOLOGICS, INC. | |
23 | 00816085024134 | 0 | 0003339 | Methanol, Absolute | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
24 | 00816085024097 | 0 | 0004820 | NALC Diluent | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
25 | 00816085024080 | 0 | X000489 | NALC Diluent | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
26 | 00816085024035 | 0 | 0003516 | 0.9% Saline 4.0ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
27 | 00816085024028 | 0 | 0003520 | 0.9% Saline 4.5ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
28 | 00816085024011 | 0 | 0003521 | 0.9% Saline 5.0ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
29 | 00816085023403 | 0 | 0003510 | MUCOSOL (Cleland's Reagent) 15x10ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
30 | 00816085023281 | 0 | 0003471 | 4% NaOH 250ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
31 | 00816085023267 | 0 | AFB Base Decontamination Reagent (2.0%) 100ml bottle | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. | |
32 | 00816085023250 | 0 | Sodium Citrate Solution 250ml bottle | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. | |
33 | 00816085023168 | 0 | 0003464 | AFB Base Decontamination Reagent (2.0%) | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
34 | 00816085023137 | 0 | 0003458 | Sodium Citrate Solution | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
35 | 00816085023113 | 0 | AFB Base Decontamination Reagent (3.0%) 500ml bottle | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. | |
36 | 00816085023106 | 0 | 0003455 | AFB Base Decontamination Reagent (3.0%) | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
37 | 00816085023090 | 0 | AFB Base Decontamination Reagent (4.0%) 250ml bottle | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. | |
38 | 00816085023076 | 0 | MYCO-PAC 50ml bottle | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. | |
39 | 00816085023069 | 0 | 0003453 | MYCO-PAC 5x50ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
40 | 00816085023038 | 0 | 0003450 | NALC Bulk 50g | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
41 | 00816085023014 | 0 | Bromothymol Blue Solution 30ml bottle | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. | |
42 | 00816085023007 | 0 | 0003448 | Bromothymol Blue Solution | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
43 | 00816085022987 | 0 | 0003446 | NALC Bulk 100g | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
44 | 00816085022956 | 0 | AFB Base Decontamination Reagent (2.0%) 250ml bottle | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. | |
45 | 00816085022901 | 0 | 0003439 | 4 % Sulfuric Acid Solution 125ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
46 | 00816085022871 | 0 | 4% NaOH 250ml bottle | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. | |
47 | 00816085022864 | 0 | 0003436 | Sodium Hydroxide Solution (4%) | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
48 | 00816085022789 | 0 | 0003356 | 95% Ethanol 1L | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
49 | 00816085022758 | 0 | 0003350 | 90% Acid-Ethanol 500ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |
50 | 00816085022734 | 0 | 0003344 | Ethyl Acetate 500ml | Alpha-Tec Systems | ALPHA-TEC SYSTEMS, INC. |