NA
- Primary DI
- 05056080500911
- Brand
- NA
- Company
- REMEL EUROPE LIMITED
- Model
- R30163801
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
remel.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 |
|---|---|---|---|---|
| 05056080500911 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05056080500911 | 05056080500911 | 5056080500911 |
GMDN Terms
| Term | Definition |
|---|---|
| Multiple Shigella species culture isolate 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 one or multiple species of Shigella bacteria isolated by culture from a clinical specimen, using an agglutination method. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +4401322295600 | ITechnicalSupport@remel.com |
Regulatory Flags
- DUNS number
- 232600853
- 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
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05056080500775 | Salmonella H z Agglutinating Sera | R30162401 | 2021-07-21 | |
| 05056080501031 | Vibrio cholerae Inaba Agglutinating Sera | R30165101 | 2021-07-21 | |
| 05056080501239 | PathoDx Strep Grouping Kit | R62025 | 2021-07-21 | |
| 05056080501246 | PathoDx Strep A Grouping Latex | R62030 | 2021-07-21 | |
| 05056080501253 | PathoDx Strep B Grouping Latex | R62031 | 2021-07-21 | |
| 05056080501260 | PathoDx Strep C Grouping Latex | R62032 | 2021-07-21 | |
| 05056080501277 | PathoDx Strep F Grouping Latex | R62034 | 2021-07-21 | |
| 05056080501284 | PathoDx Strep G Grouping Latex | R62035 | 2021-07-21 | |
| 05056080501291 | PathoDx Positive Control | R62042 | 2021-07-21 | |
| 05056080501307 | PathoDx Extraction Reagent 1 (7ml) | R62050 | 2021-07-21 | |
| 05056080501314 | PathoDx Extraction Reagent 1 (14ml) | R62052 | 2021-07-21 | |
| 05056080501321 | PathoDx Extraction Reagent 2 (7ml) | R62055 | 2021-07-21 | |
| 05056080501338 | PathoDx Extraction Reagent 2 (14ml) | R62057 | 2021-07-21 | |
| 05056080501345 | PathoDx Extraction Reagent 3 | R62060 | 2021-07-21 | |
| 05056080501352 | PathoDx Strep Grouping Universal Kit (60 test) | R62076 | 2021-07-21 | |
| 05056080501369 | PathoDx Strep Grouping Universal Kit (120 test) | R62150 | 2021-07-21 | |
| 05056080501376 | Streptex | R30950501 | 2021-07-21 | |
| 05056080501383 | Streptex 200 | R30164701 | 2021-07-21 | |
| 05056080501390 | Streptex Rapid | R30950555 | 2021-07-21 | |
| 05056080501406 | Streptex Latex A | R30950601 | 2021-07-21 |
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 |