NA
- Primary DI
- 00816576022151
- Brand
- NA
- Company
- HARDY DIAGNOSTICS
- Model
- 294845
- Catalog number
- 294845
- Device description
- Shigella As set 3, 2ml x 8vls
- Published
- 2016-09-17
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
hardydiagnostics.comProduct Codes
| Code | Name |
|---|---|
| GNB | Antisera, All Types, Shigella Spp. |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GNB | Antisera, All Types, Shigella Spp. | Microbiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816576022151 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816576022151 | 00816576022151 | 816576022151 | 0816576022151 |
GMDN Terms
| Term | Definition |
|---|---|
| Multiple Shigella 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 Shigella bacteria isolated by culture from a clinical specimen. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 800-266-2222 | techservice@hardydiagnostics.com |
Regulatory Flags
- DUNS number
- 039981550
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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
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| 15060392376437 | Mast Assure | MAST GROUP LIMITED | GNB | 2018-10-10 |
| 15060392376468 | Mast Assure | MAST GROUP LIMITED | GNB | 2018-10-10 |
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