Phadebact Strep B Test
- Primary DI
- 07350049850184
- Brand
- Phadebact Strep B Test
- Company
- Mkl Diagnostics AB
- Model
- 10-5585-12
- Published
- 2018-08-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- OTC
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07350049850184 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07350049850184 | 07350049850184 | 7350049850184 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 350472667
- Device count
- 1
- Premarket exempt
- true
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07350049850122 | Phadebact Pneumococcus Test | 10-5576-12 | 2018-08-20 | |
| 07350049850160 | Phadebact Streptococcus Test | 10-5583-12 | 2018-08-20 | |
| 07350049850177 | Phadebact Strep A Test | 10-5584-12 | 2018-08-20 | |
| 07350049850191 | Phadebact Strep D Test | 10-5586-12 | 2018-08-20 | |
| 07350049850207 | Phadebact Strep F Test | 10-5587-12 | 2018-08-20 | |
| 07350049850214 | Phadebact Strep Positive Controls | 10-5590-12 | 2018-08-20 | |
| 07350049850238 | Phadebact CSF Positive Controls | 10-5593-12 | 2018-08-20 | |
| 07350049850245 | Phadebact GC Positive Controls | 10-5594-12 | 2018-08-20 | |
| 07350049850115 | Phadebact Haemophilus Test | 10-5575-12 | 10-5575-12 | 2016-11-17 |
| 07350049850221 | Phadebact CSF Test | 10-5592-12 | 10-5592-12 | 2016-11-17 |
| 07350049850269 | Phadebact Monoclonal GC Test | 10-6419-12 | 10-6419-12 | 2016-11-17 |