NA
- Primary DI
- 00816576022366
- Brand
- NA
- Company
- HARDY DIAGNOSTICS
- Model
- 294104
- Catalog number
- 294104
- Device description
- Salmonella As Hw. 5ml
- 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
Product Codes
| Code | Name |
|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. | Microbiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816576022366 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816576022366 | 00816576022366 | 816576022366 | 0816576022366 |
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 |
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
- 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
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| 15060392376048 | Mast Assure Antisera | MAST GROUP LIMITED | GRM | 2018-11-23 |
| 15060392376079 | Mast Assure Antisera | MAST GROUP LIMITED | GRM | 2018-11-19 |
| 15060392375904 | Mast Assure | MAST GROUP LIMITED | GRM | 2018-10-10 |
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| 15060392376017 | Mast Assure Antisera | MAST GROUP LIMITED | GRM | 2018-08-23 |