NA
- Primary DI
- 00816576022656
- Brand
- NA
- Company
- HARDY DIAGNOSTICS
- Model
- 295101
- Catalog number
- 295101
- Device description
- Shigella boydii type 10 antisera, 2ml
- Published
- 2017-03-28
- 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 |
|---|---|---|---|---|
| 00816576022656 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816576022656 | 00816576022656 | 816576022656 | 0816576022656 |
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
- 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
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00816576027958 | N/A | W95 | W95 | 2020-06-08 |
| 00819398024594 | N/A | Y100 | Y100 | 2020-06-08 |
| 00819398023603 | N/A | R76BX | R76BX | 2020-06-05 |
| 00819398024235 | HardyFlask™ | X26 | X26 | 2020-06-08 |
| 00816576027088 | HardyDisk™ | Z9491 | Z9491 | 2025-08-08 |
| 00816576026975 | HardyDisk™ | Z9485 | Z9485 | 2025-07-14 |
| 00816576027439 | QwikID | IG06020C03 | IG06020C03 | 2025-06-23 |
| 00819398027199 | N/A | Z134 | Z134 | 2020-06-10 |
| 00819398027779 | N/A | Z135 | Z135 | 2020-06-10 |
| 00816576023516 | N/A | 1020 | 1020 | 2020-05-26 |
| 00816576025800 | TransPRO | TPV50 | TPV50 | 2024-10-08 |
| 00816576026951 | N/A | G367 | G367 | 2024-07-08 |
| 00816576026586 | N/A | J139 | J139 | 2020-05-20 |
| 00816576026876 | N/A | R12 | R12 | 2024-03-08 |
| 00819398021593 | N/A | R63BX | R63BX | 2024-01-15 |
| 00819398020602 | N/A | K02 | K02 | 2020-05-24 |
| 00816576026838 | HardyCHROM™ | J28 | J28 | 2023-12-08 |
| 00816576024391 | AnaeroGRO | AG051 | AG051 | 2020-05-12 |
| 00819398020725 | HardyDisk™ | Z9465 | Z9465 | 2023-11-21 |
| 00819398023627 | N/A | R80 | R80 | 2020-06-05 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 15060392376390 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-10-15 |
| 15060392377861 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-10-15 |
| 15060392377717 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-08-05 |
| 15060392377700 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-06-16 |
| 15060392377724 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-06-16 |
| 15060392377731 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-06-16 |
| 15060392377748 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-06-16 |
| 15060392377755 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-06-16 |
| 15060392376345 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-06-07 |
| 15060392377694 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2021-06-07 |
| 00083059100952 | EZ-SHIGELLA One-Step Shigella species Rapid Test | BIOMERICA, INC. | GNB | 2020-07-01 |
| 08305901009155 | EZ-SHIGELLA One-Step Shigella species Rapid Test | BIOMERICA, INC. | GNB | 2020-01-10 |
| 15060392377915 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2019-02-22 |
| 15060392377977 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2019-02-22 |
| 15060392378004 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2019-02-22 |
| 15060392376413 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-12-05 |
| 15060392376406 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-11-09 |
| 15060392377830 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-11-09 |
| 15060392378011 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-11-09 |
| 15060392378028 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-11-09 |
| 15060392376437 | Mast Assure | MAST GROUP LIMITED | GNB | 2018-10-10 |
| 15060392376468 | Mast Assure | MAST GROUP LIMITED | GNB | 2018-10-10 |
| 15060392376475 | Mast Assure | MAST GROUP LIMITED | GNB | 2018-10-10 |
| 15060392376482 | Mast Assure | MAST GROUP LIMITED | GNB | 2018-10-10 |
| 15060392376376 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-09-20 |
| 15060392377809 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-09-20 |
| 15060392377823 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-08-17 |
| 15060392377847 | Mast Assure Antisera | MAST GROUP LIMITED | GNB | 2018-08-17 |
| 15060392378035 | Shigella Antisera Set 2 | MAST GROUP LIMITED | GNB | 2018-08-17 |
| 15060392378042 | Mast Assure | MAST GROUP LIMITED | GNB | 2018-08-17 |