NA
- Primary DI
- 05056080501192
- Brand
- NA
- Company
- REMEL EUROPE LIMITED
- Model
- R30167201
- 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 |
|---|---|
| GTJ | Antisera, All Groups, N. Meningitidis |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GTJ | Antisera, All Groups, N. Meningitidis | Microbiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05056080501192 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05056080501192 | 05056080501192 | 5056080501192 |
GMDN Terms
| Term | Definition |
|---|---|
| Neisseria meningitidis 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 Neisseria meningitidis 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 |
|---|---|---|---|---|
| 05056080501567 | EDTA Solution | REMEL EUROPE LIMITED | GTJ | 2021-07-21 |
| 07350049850221 | Phadebact CSF Test | Mkl Diagnostics AB | GTJ | 2016-11-17 |
| 05056080500973 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080500980 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080500997 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501130 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501147 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501154 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501161 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501178 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501185 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501208 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501215 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 05056080501222 | NA | REMEL EUROPE LIMITED | GTJ | 2016-09-24 |
| 00382902555605 | BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit | BECTON, DICKINSON AND COMPANY | GTJ | 2016-07-07 |
| 30382902523506 | BD Directigen™ Meningitis Test Negative Control Re | BECTON, DICKINSON AND COMPANY | GTJ | 2016-05-19 |
| 00382902523604 | BD Directigen™ Meningitis Combo Test Kit | BECTON, DICKINSON AND COMPANY | GTJ | 2016-05-19 |
| 00382902524809 | BD Directigen™ Meningitis Combo Test Cards | BECTON, DICKINSON AND COMPANY | GTJ | 2016-05-19 |
| 00382902563914 | BD Directigen™ Specimen Buffer Solution | BECTON, DICKINSON AND COMPANY | GTJ | 2016-05-19 |
| 00382902288114 | BD Difco™ Neisseria Meningitidis Antiserum Group Y | BECTON, DICKINSON AND COMPANY | GTJ | 2016-05-03 |
| 00382902289111 | BD Difco™ Neisseria Meningitidis Antiserum Group Z | BECTON, DICKINSON AND COMPANY | GTJ | 2016-05-03 |
| 00382902291015 | BD Difco™ Neisseria Meningitidis Antiserum Poly 2 Contains Groups X, Y, Z | BECTON, DICKINSON AND COMPANY | GTJ | 2016-05-03 |
| 00382902225218 | BD Difco™ Neisseria Meningitidis Antiserum Group Z | BECTON, DICKINSON AND COMPANY | GTJ | 2016-04-29 |
| 00382902225317 | BD Difco™ Neisseria Meningitidis Antiserum Group W135 | BECTON, DICKINSON AND COMPANY | GTJ | 2016-04-29 |
| 00382902288015 | BD Difco™ Neisseria Meningitidis Antiserum Group X | BECTON, DICKINSON AND COMPANY | GTJ | 2016-04-29 |
| 00382902222811 | BD Difco™ Neisseria Meningitidis Antiserum Group A | BECTON, DICKINSON AND COMPANY | GTJ | 2016-04-28 |
| 00382902222910 | BD Difco™ Neisseria Meningitidis Antiserum Group B | BECTON, DICKINSON AND COMPANY | GTJ | 2016-04-28 |
| 00382902223016 | BD Difco™ Neisseria Meningitidis Antiserum Group C | BECTON, DICKINSON AND COMPANY | GTJ | 2016-04-28 |
| 00382902223115 | BD Difco™ Neisseria Meningitidis Antiserum Group D | BECTON, DICKINSON AND COMPANY | GTJ | 2016-04-28 |
| 00382902223214 | BD Difco™ Neisseria Meningitidis Antiserum Poly Contains Groups A, B, C, D | BECTON, DICKINSON AND COMPANY | GTJ | 2016-04-28 |