FDA UDI
In Commercial Distribution
🇺🇸 United States
QC Sets and Panels: Helix Elite™
DI: 70845357043732
·
Model: 8249
·
MICROBIOLOGICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- QC Sets and Panels: Helix Elite™
- Primary DI
- 70845357043732
- Version / Model
- 8249
- Catalog Number
- 8249
- Company Name
- MICROBIOLOGICS INC.
- Labeler DUNS
- 060467826
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-16
- Public Version
- 3
- Public Version Date
- 2025-05-09
- Public Version Status
- Update
- Public Device Record Key
- 55c5a0fc-d0a2-4346-9254-19ad21ac3f7b
Device Description
QC Sets and Panels: Helix Elite™ Molecular Standards Bacterial vaginosis (BV) Control Panel
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 |
|---|---|---|---|---|
| 48210 | Multiple vaginitis/vaginosis-associated 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 acid from multiple types of pathogens associated with vaginitis and/or vaginosis in a clinical specimen. Pathogens intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 70845357043732 | GS1 |
Customer Contacts
- Phone
- +1(320)253-7400
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius