No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10190302004053 | 31100035 | KIT | MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE | Medium 199, Earle's | |||
2 | 10190302003766 | 22400071 | KIT | MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE | 1 | RPMI Medium 1640 | ||
3 | 10190302003346 | 21010046 | KIT | MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE | Basal Medium Eagle (BME) | |||
4 | 10190302001663 | 11095072 | KIT | MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE | 1 | MEM Earles | ||
5 | 10859952006014 | A40400 | Di Description | GGK,OZE,JJX | PRODUCTS, RED-CELL LYSING PRODUCTS,Influenza A and influenza B multiplex nucleic PRODUCTS, RED-CELL LYSING PRODUCTS,Influenza A and influenza B multiplex nucleic acid assay,Single (specified) analyte controls (assayed and unassayed) | Brand name | ||
6 | 10190302010917 | MHCD2304 | MVU | Reagents, specific, analyte | 1 | Human CD23 R-PE Conjugate | ||
7 | 10190302010894 | MHCD2205 | MVU | Reagents, specific, analyte | 1 | Human CD22 APC Conjugate | ||
8 | 10190302010863 | MHCD2201 | MVU | Reagents, specific, analyte | 1 | Human CD22 FITC Conjugate | ||
9 | 10190302009829 | MHCD0420 | MVU | Reagents, specific, analyte | 1 | Human CD4 Alexa Fluor® 488 Conjugate | ||
10 | 10190302009799 | MHCD0417 | MVU | Reagents, specific, analyte | 1 | Human CD4 PE-Texas Red® Conjugate | ||
11 | 10190302009706 | MHCD0327 | MVU | Reagents, specific, analyte | 1 | Human CD3 APC-Alexa Fluor® 750 Conj. | ||
12 | 10190302009690 | MHCD0324 | MVU | Reagents, specific, analyte | 1 | Human CD3 PE-Alexa Fluor® 700 Conj. | ||
13 | 10190302009676 | MHCD0320 | MVU | Reagents, specific, analyte | 1 | Human CD3 Alexa Fluor® 488 Conjugate | ||
14 | 10190302008617 | CD11B04 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD11b (Mac-1) R-PE Conjugate | ||
15 | 10190302008549 | CD11700 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD117 Purified Antibody | ||
16 | 10190302008488 | CD0329 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD3 Alexa Fluor® 700 Conjugate | ||
17 | 10190302008433 | CD0301 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD3 FITC Conjugate | ||
18 | 10190302008426 | CD0231 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD2 PerCP Conjugate | ||
19 | 10190302008402 | CD0217 | MVU | REAGENTS,SPECIFIC,ANALYTE | 1 | Human CD2 PE-Texas Red® Conjugate | ||
20 | 10190302007221 | A26923 | MVU | Reagents, specific, analyte | 1 | MGB PROBE 100 NMOL VIC | ||
21 | 10190302005494 | MHCD1904 | GKZ | Counter, differential cell | 2 | Human CD19 R-PE Conjugate | ||
22 | 10190302017756 | A51694 | PQP | Next generation sequencing oncology panel, somatic or germline variant detection system | 3 | Oncomine™ Dx Target Test User Guides and Assay Definition File | ||
23 | 10190302017312 | A52570, V1.1.0 | OOI | real time Nucleic acid amplification system | 2 | SAE Admin Console Dx Software V1.1.0 Kit | ||
24 | 10190302015646 | A49678 | PQP | Next generation sequencing oncology panel, somatic or germline variant detection system | 3 | Oncomine™ Dx Target Test User Guide and Assay Definition File | ||
25 | 10190302015080 | A44551 | MVU | Reagents, specific, analyte | 1 | SMA_Si_WTProbe | ||
26 | 10190302015066 | A41856 | PCA | DNA genetic analyzer | 2 | 3500 Dx Series Data Collection Software 3 IVD Version 3.2 | ||
27 | 10190302014946 | A14326 | MVU | Reagents, specific, analyte | 1 | HSV Probe | ||
28 | 10190302014335 | A38872 | PQP | Next generation sequencing oncology panel, somatic or germline variant detection system | 3 | Oncomine™ Dx Target RNA Control Diluent | ||
29 | 10190302012270 | MHZAP70044 | MVU | Reagents, specific, analyte | 1 | Anti-Human/Mouse ZAP-70 R-PE Conjugate | ||
30 | 10190302012171 | MHLDR04 | MVU | Reagents, specific, analyte | 1 | Anti-Human HLA-DR (Class II) R-PE Conjugate | ||
31 | 10190302012157 | MHKI6701 | MVU | Reagents, specific, analyte | 1 | Anti-Human Ki-67 FITC Conjugate | ||
32 | 10190302012140 | MHGLA044 | MVU | Reagents, specific, analyte | 1 | Anti-Human Glycophorin A (CD235a) R-PE Conjugate | ||
33 | 10190302012133 | MHGLA04 | MVU | Reagents, specific, analyte | 1 | Anti-Human Glycophorin A (CD235a) R-PE Conjugate | ||
34 | 10190302012010 | MHCD8624 | MVU | Reagents, specific, analyte | 1 | Human CD86 (B7-2/B70) PE-Alexa Fluor® 700 Conj. | ||
35 | 10190302011983 | MHCD8601 | MVU | Reagents, specific, analyte | 1 | Human CD86 (B7-2/B70) FITC Conjugate | ||
36 | 10190302011938 | MHCD8001 | MVU | Reagents, specific, analyte | 1 | Human CD80 (B7-1, BB1) FITC Conjugate | ||
37 | 10190302011921 | MHCD79B04 | MVU | Reagents, specific, analyte | 1 | Human CD79b R-PE Conjugate | ||
38 | 10190302011822 | MHCD65S01 | MVU | Reagents, specific, analyte | 1 | Human CD65s FITC Conjugate | ||
39 | 10190302011709 | MHCD5620 | MVU | Reagents, specific, analyte | 1 | Human CD56 Alexa Fluor® 488 Conjugate | ||
40 | 10190302011617 | MHCD55044 | MVU | Reagents, specific, analyte | 1 | Human CD55 R-PE Conjugate | ||
41 | 10190302011600 | MHCD5504 | MVU | Reagents, specific, analyte | 1 | Human CD55 R-PE Conjugate | ||
42 | 10190302011495 | MHCD45RA17 | MVU | Reagents, specific, analyte | 1 | Human CD45RA PE-Texas Red® Conjugate | ||
43 | 10190302011402 | MHCD4520 | MVU | Reagents, specific, analyte | 1 | Human CD45 Alexa Fluor® 488 Conjugate | ||
44 | 10190302011334 | MHCD4505 | MVU | Reagents, specific, analyte | 1 | Human CD45 APC Conjugate | ||
45 | 10190302011228 | MHCD42B04 | MVU | Reagents, specific, analyte | 1 | Human CD42b R-PE Conjugate | ||
46 | 10190302011204 | MHCD4104 | MVU | Reagents, specific, analyte | 1 | Human CD41 R-PE Conjugate | ||
47 | 10190302011143 | MHCD3817 | MVU | Reagents, specific, analyte | 1 | Human CD38 PE-Texas Red® Conjugate | ||
48 | 10190302011112 | MHCD38014 | MVU | Reagents, specific, analyte | 1 | Human CD38 FITC Conjugate | ||
49 | 10190302011105 | MHCD3801 | MVU | Reagents, specific, analyte | 1 | Human CD38 FITC Conjugate | ||
50 | 10190302011037 | MHCD2704 | MVU | Reagents, specific, analyte | 1 | Human CD27 R-PE Conjugate |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 17503025060276 | A11474 | Test Device Description | This is to test the length of the brand field and what it looks like in the GUDI | LIFE TECHNOLOGIES CORPORATION | |
2 | 15420045512924 | INTERNAL CONTROL-B, 960T, IVD | PRD-06234 | Panther Fusion | HOLOGIC, INC. | |
3 | 15420045512917 | EXTRACTION REAGENTS-B, 960T, IVD | PRD-06232 | Panther Fusion | HOLOGIC, INC. | |
4 | 15420045506732 | HOLOGIC DNA EXTRACTION KIT - DOMESTIC | PRD-00855 | INVADER | HOLOGIC, INC. | |
5 | 10190302006323 | A32439 | Ion Torrent™Dx Sample Dilution Kit | LIFE TECHNOLOGIES CORPORATION | ||
6 | 10190302006316 | A32438 | Ion Torrent™ Dx RNA Quantification Kit | LIFE TECHNOLOGIES CORPORATION | ||
7 | 10190302006309 | A32437 | Ion Torrent™ Dx DNA Quantification Kit | LIFE TECHNOLOGIES CORPORATION | ||
8 | 10190302006293 | A32436 | Ion Torrent™ Dx cDNA Synthesis Kit | LIFE TECHNOLOGIES CORPORATION | ||
9 | 10190302006286 | A32435 | Ion Torrent™ Dx Total NA Isolation Kit (RT) | LIFE TECHNOLOGIES CORPORATION | ||
10 | 10190302006101 | A32434 | Ion Torrent™ Dx Total NA Isolation Kit (-20 C) | LIFE TECHNOLOGIES CORPORATION | ||
11 | 10190302005821 | A28783 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | ||
12 | 10190302005814 | A28782 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | ||
13 | 10190302005807 | A28781 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | ||
14 | 10190302005791 | A28780 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | ||
15 | 10190302005784 | A28779 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | ||
16 | 10190302005258 | A30321 | Ion Torrent | LIFE TECHNOLOGIES CORPORATION | ||
17 | 08885013958188 | 300677 | 300677 | The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nu The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nucleic acid extraction from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 on the Sentosa® SX101 instrument. | ViroKey™ SX Virus Total Nucleic Acid Kit | VELA OPERATIONS SINGAPORE PTE. LTD. |
18 | 08885013958171 | 300395 | 300395 | The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic bea The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use. | Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) | VELA OPERATIONS SINGAPORE PTE. LTD. |
19 | 08885013958157 | 300353 | 300353 | The Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for magnetic bea The Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use. | Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) | VELA OPERATIONS SINGAPORE PTE. LTD. |
20 | 08809537077750 | A-5030 | ExiPrep™16 Plus | BIONEER CORPORATION | ||
21 | 08809537070461 | K-4731 | K-4731 | 384 test/kit | Protonion™ 96 Viral RNA Kit | BIONEER CORPORATION |
22 | 08809537070188 | A-5250 | ExiPrep™96 Lite | BIONEER CORPORATION | ||
23 | 08809537070065 | A-5050 | ExiPrep™16 Dx | BIONEER CORPORATION | ||
24 | 08809537070058 | A-5150 | ExiPrep™48 Dx | BIONEER CORPORATION | ||
25 | 08809357179870 | K-4611 | K-4611 | 384 test/kit | ExiPrep™ 96 Genomic DNA Kit | BIONEER CORPORATION |
26 | 08809357179498 | K-3617 | K-3617 | 100 test/kit | MagListo™ 5M Viral DNA/RNA Extraction Kit | BIONEER CORPORATION |
27 | 08809357179481 | K-4614 | K-4614 | 384 test/kit | ExiPrep™ 96 Viral DNA/RNA Kit | BIONEER CORPORATION |
28 | 08809357178316 | K-4573 | K-4573 | 96 test/kit | ExiPrep™ 48 Viral RNA Kit | BIONEER CORPORATION |
29 | 08809357178309 | K-4571 | K-4571 | 96 test/kit | ExiPrep™ 48 Viral DNA/RNA Kit | BIONEER CORPORATION |
30 | 08809357174233 | K-4418 | K-4418 | 96 test/kit | ExiPrep™ Dx Mycobacteria Genomic DNA Kit | BIONEER CORPORATION |
31 | 08809357174219 | K-4414 | K-4414 | 96 test/kit | ExiPrep™ Dx Bacteria Genomic DNA Kit | BIONEER CORPORATION |
32 | 08809357174196 | K-4411 | K-4411 | 96 test/kit | ExiPrep™ Dx Blood Genomic DNA Kit | BIONEER CORPORATION |
33 | 08809357174172 | K-4472 | K-4472 | 96 test/kit | ExiPrep™ Dx Viral DNA Kit | BIONEER CORPORATION |
34 | 08809357174158 | K-4471 | K-4471 | 96 test/kit | ExiPrep™ Dx Viral DNA/RNA Kit | BIONEER CORPORATION |
35 | 08809357174134 | K-4473 | K-4473 | 96 test/kit | ExiPrep™ Dx Viral RNA Kit | BIONEER CORPORATION |
36 | 08806133010242 | FPRR032 | NuActor | BODITECH MED INC. | ||
37 | 08800204300683 | AP010 | RADI PREP PLUS Universal DNA/RNA KIT | KH MEDICAL CO., LTD. | ||
38 | 08800204300577 | AP105 | RADI 48 Bacteria DNA Extraction Kit | KH MEDICAL CO., LTD. | ||
39 | 08800204300560 | AP104 | RADI 48 Tissue DNA Extraction Kit | KH MEDICAL CO., LTD. | ||
40 | 08800204300553 | AP103 | RADI 48 Whole Blood DNA/RNA Extraction Kit | KH MEDICAL CO., LTD. | ||
41 | 08800204300546 | AP101 | RADI PREP PLUS 48 Swab DNA,RNA Extraction Kit | KH MEDICAL CO., LTD. | ||
42 | 08800204300539 | AP102 | RADI 48 Viral DNA/RNA Extraction kit | KH MEDICAL CO., LTD. | ||
43 | 08800204300300 | AP006 | RADI PREP PLUS Swab and Stool DNARNA KIT | KH MEDICAL CO., LTD. | ||
44 | 08800204300133 | OE005 | RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 32 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 32 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System. | RADI Extractor 32 | KH MEDICAL CO., LTD. | |
45 | 08800204300102 | KM003 | The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic ac The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic acid extraction and purification from various biological samples including tissue, cell culture, whole blood, serum, plasma, swab, Bacteria, yeast, etc. | RADI PREP Plus 48 | KH MEDICAL CO., LTD. | |
46 | 08800204300027 | OE006 | RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 192 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 192 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System. | RADI Extractor 192 | KH MEDICAL CO., LTD. | |
47 | 08800204300010 | KM001 | RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nuclei RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI PREP PLUS instrument is designed for use by laboratory professionals. 8 samples can be prepared in a single run. This Instrument is controlled through a graphical user interface.RADI PREP PLUS has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the 7 inches LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System. | RADI PREP Plus | KH MEDICAL CO., LTD. | |
48 | 06975064320002 | ZRM-C-AH-A | Automatic High-throughput Exosome Extractor | ZHAORUI MEDICAL (SHENZHEN) CO., LTD | ||
49 | 06973685478027 | ANDiS 396 | 3000000000414 | The device is used for extraction and purification of nucleic acid in clinical samples. | Automated Nucleic Acids Extraction System ANDiS 396 | 3D BIOMEDICINE SCIENCE & TECHNOLOGY CO., LIMITED |
50 | 06973685478010 | ANDiS 360 | 3000000000044 | The device is an automated system, used for extraction and purification of nucle The device is an automated system, used for extraction and purification of nucleic acid from clinical specimens. | Automated Nucleic Acids Extraction System ANDiS 360 | 3D BIOMEDICINE SCIENCE & TECHNOLOGY CO., LIMITED |