Product code GRP
- Device name
- Antisera, All Types, H. Influenza
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3300
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884967 | BACTIGEN(R) H. INFLUENZAE TYPE B | Armkel, LLC | 1989-02-07 |
| K854490 | IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES | American Micro Scan | 1985-12-27 |
| K831525 | H-FLU B ELISA TEST | Seragen Diagnostics, Inc. | 1983-09-29 |
| K823348 | H. INFLUENZA B ANTISERA FOR CIE | Diagnostica, Inc. | 1982-12-28 |
| K821266 | BBL DIRECTIGEN MENINGITIS TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-01 |
| K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | Hyland Therapeutic Div., Travenol Laboratories | 1982-03-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15060392377601 | Mast Assure Antisera | MAST GROUP LIMITED | 2022-04-06 |
| 15060392376338 | Mast Assure Antisera | MAST GROUP LIMITED | 2021-09-22 |
| 04048474025309 | Haemophilus influenza B IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-06 |
| 00404847425307 | Haemophilus influenza B IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-06 |
| 15060392377564 | Mast Assure Antisera | MAST GROUP LIMITED | 2018-12-12 |
| 15060392377571 | Mast Assure Antisera | MAST GROUP LIMITED | 2018-08-17 |
| 07350049850115 | Phadebact Haemophilus Test | Mkl Diagnostics AB | 2016-11-17 |
| 05056080501093 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080501123 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080501116 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080501109 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080501086 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05056080501079 | NA | REMEL EUROPE LIMITED | 2016-09-24 |
| 05051700006767 | VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05713106914601 | ImmuLex H. influenzae type a antiserum, 1,5 mL | Ssi Diagnostica A/S | 2016-09-13 |
| 05713106914670 | ImmuLex H. influenzae polyv. Antiserum, 1,5mL | Ssi Diagnostica A/S | 2016-09-13 |
| 05713106914656 | ImmuLex H. influenzae type f antiserum, 1,5mL | Ssi Diagnostica A/S | 2016-09-13 |
| 05713106914649 | ImmuLex H. influenzae type e antiserum, 1,5mL | Ssi Diagnostica A/S | 2016-09-13 |
| 05713106914625 | ImmuLex H. influenzae type d antiserum, 1,5mL | Ssi Diagnostica A/S | 2016-09-13 |
| 05713106914618 | ImmuLex H. influenzae type c antiserum, 1,5 mL | Ssi Diagnostica A/S | 2016-09-13 |
| 05713106852057 | ImmuLex H. influenzae type b antiserum, 1,5 mL | Ssi Diagnostica A/S | 2016-09-13 |
| 05713106034620 | H. influenzae Type b serum, 1 mL | Ssi Diagnostica A/S | 2016-09-13 |
| 00382902223719 | BD Difco™ Haemophilus influenzae Antiserum Poly Contains Types a, b, c, d, e, f | BECTON, DICKINSON AND COMPANY | 2016-07-07 |
| 00382902522607 | BD Directigen™ H. influenzae type b Test Kit | BECTON, DICKINSON AND COMPANY | 2016-05-19 |
| 00382902278917 | BD Difco™ Haemophilus influenzae Antiserum Type c | BECTON, DICKINSON AND COMPANY | 2016-04-29 |
| 00382902279013 | BD Difco™ Haemophilus influenzae Antiserum Type d | BECTON, DICKINSON AND COMPANY | 2016-04-29 |
| 00382902279112 | BD Difco™ Haemophilus Influenzae Antiserum Type e | BECTON, DICKINSON AND COMPANY | 2016-04-29 |
| 00382902279211 | BD Difco™ Haemophilus Influenzae Antiserum Type f | BECTON, DICKINSON AND COMPANY | 2016-04-29 |
| 00382902223610 | BD Difco™ Haemophilus Influenzae Antiserum Type b | BECTON, DICKINSON AND COMPANY | 2016-04-28 |
| 00382902225010 | BD Difco™ Haemophilus Influenzae Antiserum Type a | BECTON, DICKINSON AND COMPANY | 2016-04-28 |