FDA UDI
In Commercial Distribution
🇺🇸 United States
QC Sets and Panels: Helix Elite™
DI: 70845357041370
·
Model: 8200 Cepheid Xpert® C. difficile/Epi Control Panel
·
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
- 70845357041370
- Version / Model
- 8200 Cepheid Xpert® C. difficile/Epi Control Panel
- Catalog Number
- 8200
- Company Name
- MICROBIOLOGICS INC.
- Labeler DUNS
- 060467826
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-31
- Public Version
- 2
- Public Version Date
- 2019-08-16
- Public Version Status
- Update
- Public Device Record Key
- cb5e6e3c-7dfd-46c0-98e3-8ec0953fc5e5
Device Description
Cepheid Xpert® C. difficile/Epi Control Panel
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | Microbiology | 866.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50838 | Clostridium difficile 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, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] 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 | 70845357041370 | GS1 |
Customer Contacts
- Phone
- +1 (320) 253-7400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190463 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius