FDA UDI
In Commercial Distribution
🇺🇸 United States
DSQ Alert™ MS2-ICB-1 Internal Control Set
DI: 03661540952098
·
Model: M800707
·
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™ MS2-ICB-1 Internal Control Set
- Primary DI
- 03661540952098
- Version / Model
- M800707
- Catalog Number
- M800707
- 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
- 2
- Public Version Date
- 2023-11-14
- Public Version Status
- Update
- Public Device Record Key
- 4b4f6953-042b-442c-955e-770a02aad59c
Device Description
The DSQ Alert MS2-ICB-1 Internal Control Set consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2-ICB-1 Internal Control Set can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. This set is not intended to monitor other real-time PCR processes.
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 |
|---|---|---|---|---|
| OLD | Internal Polymerase Chain Reaction Control, Not Assay Specific | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60094 | Exogenous DNA/RNA internal control IVD, kit | A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540952098 | GS1 |
Customer Contacts
- Phone
- 8004532725
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -10 Degrees Celsius