FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Simplexa™ Bordetella Direct
DI: 20816101025620
·
Model: MOL2750
·
DIASORIN MOLECULAR LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Simplexa™ Bordetella Direct
- Primary DI
- 20816101025620
- Version / Model
- MOL2750
- Catalog Number
- MOL2750
- Company Name
- DIASORIN MOLECULAR LLC
- Labeler DUNS
- 080271715
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-24
- Public Version
- 2
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 9e7709be-0d1d-4f9c-bb55-ef8686019cc7
- Distribution End Date
- 2018-08-24
Device Description
Simplexa™ Bordetella Direct
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 |
|---|---|---|---|---|
| OZZ | Bordetella Pertussis Dna Assay System | Microbiology | 866.3980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58957 | Multiple respiratory disease-associated bacteria 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 from multiple bacteria associated with upper and/or lower respiratory disease, which may include multiple genes conferring resistance to antimicrobial drugs, in a clinical specimen using a nucleic acid technique (NAT). Bacteria detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, Chlamydia pneumonia, Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20816101025620 | GS1 |
Customer Contacts
- Phone
- (800)838-4548
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -10 Degrees Celsius