Vision 2
- Primary DI
- 00817978024170
- Brand
- Vision 2
- Company
- PRO-LAB, INCORPORATED
- Model
- PLA417
- Device description
- Shigella boydii type 7
- Published
- 2016-11-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | Microbiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00817978024170 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Multiple Salmonella species culture isolate antigen IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple species of Salmonella bacteria isolated by culture from a clinical specimen. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| 512-832-9145 | support@pro-lab.us |
Regulatory Flags
- DUNS number
- 960418395
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00817978020011 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020028 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020035 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020080 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020103 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020110 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020226 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020233 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020240 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020257 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020264 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020271 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020288 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020295 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020301 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020318 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020325 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020332 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020349 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020356 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020363 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020370 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020387 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020394 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020400 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020417 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020424 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020431 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020448 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |
| 00817978020455 | Vision 2 | PRO-LAB, INCORPORATED | GNC | 2016-11-17 |