HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
ELITechGroup
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1717966 | 1717966 | ELITechGroup Inc | 1 | Y | 2026-01-01 | 370 West 1700 South LOGAN UT US 84321 |
| 3003540236 | 3003540236 | ELITechGroup MDX LLC. | 1 | Y | 2026-01-01 | 21720 23rd Dr SE, Suite 150 Bothell WA US 98021 |
| 3044320359 | 3044320359 | ELITechGroup Inc., Tucson | 1 | N | 2026-01-01 | 3950 S. Country Club Rd. Suite #470, L Tucson AZ US 85714 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03661540952739 | DSQ Alert HHV7 Probe Mix ASR - Product Description DSQ Alert® HHV-7 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the major capsid protein gene of HHV-7. The mix consists of a total of 0.64 nmol of HHV-7 probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the FAM fluorophore and has an excitation wavelength maximum of 495 nm and an emission wavelength maximum of 517 nm. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10 degrees Celsius when received. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles. Warnings and Precautions Carefully read this entire package insert. - The operator must be trained to perform high complexity work and avoid distractions that may lead to errors. - Use general precautions and wear appropriate personal protective equipment when handling the reagents. - Do not eat, drink, or smoke in designated work areas. - Wash hands thoroughly after handling reagents. - Prevent reagent carryover by working in a nuclease-free area keeping one tube open at a time during reagent preparation and PCR setup. Completed PCR tubes or sealed plates should not be opened. - Dispose of all material that has come into contact with specimens and reagents in accordance with applicable national, international, and regional regulations. | 1-833-227-3400 | mdx@elitechgroup.com |
| 03661540952821 | DSQ Alert® HT JCV Primer Mix ASR - DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 39.2 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 78 bp region of the gene A of JCV. Each product lot will go through functional testing with an approved test method. The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles | 1-833-227-3400 | mdx@elitechgroup.com |
| 03661540952838 | DSQ Alert® HT JCV Probe Mix ASR - Product Description DSQ Alert® HT JCV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 3.9 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP530 fluorophore and has an excitation wavelength maximum of 530 nm and an emission wavelength maximum of 550 nm. Each product lot will go through functional testing with an approved test method. Storage and Handling Requirements The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles. | 1-833-227-3400 | mdx@elitechgroup.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 32802 | 1165302587 | K863395 | WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER | CGZ | 1988-05-24 |
| 32802 | 2065332837 | K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | KTB | 1985-10-16 |
| 349362 | 1313462725 | K240854 | Accelerate Arc System | QNJ | 2024-09-26 |
| 32802 | 2043695790 | K180627 | Macroduct Advanced Model 3710 | KTB | 2018-07-27 |
| 108982 | 1764419289 | K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | PGI | 2018-10-29 |
| 108982 | 1536595845 | K132468 | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE | NQX | 2013-10-17 |
| 32802 | 1345106223 | K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | JFS | 2013-03-27 |
| 108982 | 1175636932 | K112937 | MRSA/SA ELITE MGB | NQX | 2012-06-01 |
| 108982 | 1397365503 | K083430 | REAL-TIME PCR INTERNAL CONTROL 2B SET | OLD | 2009-01-15 |
| 32802 | 1202784444 | K032608 | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | JIS | 2003-10-21 |
| 32802 | 1205576649 | K031539 | HEMOGLOBIN A1C REAGENT SET | LCP | 2003-08-06 |
| 32802 | 1711617286 | K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | KTB | 2001-03-20 |
| 32802 | 1070327260 | ||||
| 32802 | 1926202927 | ||||
| 108982 | 2031134576 | ||||
| 32802 | 1105972696 | ||||
| 32802 | 1118086861 | ||||
| 32802 | 1127690770 | ||||
| 32802 | 1143812424 | ||||
| 32802 | 1230867168 | ||||
| 32802 | 1234347663 | ||||
| 32802 | 1235547482 | ||||
| 32802 | 1275132654 | ||||
| 32802 | 1363330821 | ||||
| 32802 | 1373199278 | ||||
| 32802 | 1422949660 | ||||
| 32802 | 1617128577 | ||||
| 108982 | 1743020633 | ||||
| 32802 | 1847821436 | ||||
| 32802 | 1898370667 | ||||
| 108982 | 1915549129 | ||||
| 32802 | 1936648840 | ||||
| 108982 | 1946864853 | ||||
| 32802 | 2031134576 | ||||
| 32802 | 2041971128 |
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