FDA UDI
In Commercial Distribution
🇺🇸 United States
DSQ Alert HT Candida auris Primer Mix ASR, 192 rxn Final Assembly
DI: 03661540952562
·
Model: M800760
·
Elitechgroup Mdx LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- DSQ Alert HT Candida auris Primer Mix ASR, 192 rxn Final Assembly
- Primary DI
- 03661540952562
- Version / Model
- M800760
- Catalog Number
- M800760
- Company Name
- Elitechgroup Mdx LLC
- Labeler DUNS
- 117458512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-21
- Public Version
- 1
- Public Version Date
- 2023-09-29
- Public Version Status
- New
- Public Device Record Key
- 1a46fcc7-2060-4ac7-9754-efbc70cb939a
Device Description
DSQ Alert™ HT Candida auris Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 39.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 124 bp region of the ITS2 gene of Candida auris.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65248 | Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from the yeast Candida auris in a clinical specimen, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540952562 | GS1 |
Customer Contacts
- Phone
- 8004532725
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -10 Degrees Celsius