FDA UDI
Not in Commercial Distribution
🇺🇸 United States
QC Sets and Panels: Helix Elite™
DI: 70845357041165
·
Model: 8215
·
MICROBIOLOGICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QC Sets and Panels: Helix Elite™
- Primary DI
- 70845357041165
- Version / Model
- 8215
- Catalog Number
- 8215
- Company Name
- MICROBIOLOGICS INC.
- Labeler DUNS
- 060467826
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 3
- Public Version Date
- 2023-04-05
- Public Version Status
- Update
- Public Device Record Key
- 91f0b526-8eda-4efe-baff-8c0bd3b72dc9
- Distribution End Date
- 2023-04-04
Device Description
QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Control Panel (Inactivated)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 61314 | Multiple-type bloodstream pathogen nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 70845357041165 | GS1 |
Customer Contacts
- Phone
- +1(320)253-7400
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius