| Primary Device ID | 03661540952562 |
| NIH Device Record Key | 1a46fcc7-2060-4ac7-9754-efbc70cb939a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DSQ Alert HT Candida auris Primer Mix ASR, 192 rxn Final Assembly |
| Version Model Number | M800760 |
| Catalog Number | M800760 |
| Company DUNS | 117458512 |
| Company Name | Elitechgroup Mdx LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com | |
| Phone | 8004532725 |
| MDx@elitechgroup.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540952562 [Primary] |
| MVU | Reagents, Specific, Analyte |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-29 |
| Device Publish Date | 2023-09-21 |
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