FDA UDI
In Commercial Distribution
🇺🇸 United States
Helix Elite™ Molecular Standards: Inactivated Standard
DI: 10845357042795
·
Model: HE0055NS
·
MICROBIOLOGICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Helix Elite™ Molecular Standards: Inactivated Standard
- Primary DI
- 10845357042795
- Version / Model
- HE0055NS
- Catalog Number
- HE0055NS
- Company Name
- MICROBIOLOGICS INC.
- Labeler DUNS
- 060467826
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 1
- Public Version Date
- 2020-05-08
- Public Version Status
- New
- Public Device Record Key
- 3d7dfc29-83c6-4942-bab6-ef238ae00579
Device Description
Helix Elite™ Molecular Standards Methicillin-Susceptible Staphylococcus epidermidis (MSSE) Inactivated Swab
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| OHQ | Multi-analyte controls unassayed | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62930 | Multiple Staphylococcus species 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, and/or genes conferring antimicrobial resistance, toxin production or virulence, from multiple species of Staphylococcus bacteria (e.g., S. aureus, S. epidermidis, S. hominis, S. warneri, S. simulans, S. lugdunensis) in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10845357042795 | GS1 |
Customer Contacts
- Phone
- +1(320)253-7400
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius