FDA UDI
In Commercial Distribution
🇺🇸 United States
Phadebact Strep A Test
DI: 07350049850177
·
Model: 10-5584-12
·
Mkl Diagnostics AB
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phadebact Strep A Test
- Primary DI
- 07350049850177
- Version / Model
- 10-5584-12
- Company Name
- Mkl Diagnostics AB
- Labeler DUNS
- 350472667
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-20
- Public Version
- 1
- Public Version Date
- 2018-09-20
- Public Version Status
- New
- Public Device Record Key
- ccbbe7d3-e444-4154-89a1-30f0cf588014
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51703 | Multiple Beta-haemolytic Streptococcus serogroup antigen IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple serogroups of Beta-haemolytic Streptococcus bacteria in a clinical specimen, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350049850177 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius