FDA UDI
In Commercial Distribution
🇺🇸 United States
Simplexa™ VZV Positive Control Pack
DI: 20816101025781
·
Model: MOL3660
·
DIASORIN MOLECULAR LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Simplexa™ VZV Positive Control Pack
- Primary DI
- 20816101025781
- Version / Model
- MOL3660
- Catalog Number
- MOL3660
- Company Name
- DIASORIN MOLECULAR LLC
- Labeler DUNS
- 080271715
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-19
- Public Version
- 2
- Public Version Date
- 2024-07-08
- Public Version Status
- Update
- Public Device Record Key
- 355dff3b-b1b6-4652-bb48-56fa8105c671
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | Microbiology | 866.3970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47293 | Varicella-zoster virus (VZV) 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 varicella-zoster virus (VZV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20816101025781 | GS1 |
Customer Contacts
- Phone
- 562-240-6500
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius