Product code GRZ
- Device name
- Antisera, Fluorescent, All, Mycoplasma Spp.
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3375
- 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 |
|---|---|---|---|
| K946373 | MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM | Zeus Scientific, Inc. | 1996-02-07 |
| K944417 | ZEUA MYCOPLASMA | Zeus Scientific, Inc. | 1995-08-01 |
| K931557 | FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST | Fuller Laboratories, Inc. | 1994-03-11 |
| K861716 | FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY | Whittaker Bioproducts, Inc. | 1986-08-08 |
| K840012 | INDIRECT FLUORESCENT ANTIBODY MYCO | Zeus Technologies | 1984-02-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04049016055105 | Anti-Mycoplasma pneumoniae IFA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055112 | Anti-Mycoplasma pneumoniae IFA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055129 | Anti-Mycoplasma pneumoniae IFA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055136 | Anti-Mycoplasma pneumoniae IFA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055143 | Anti-Mycoplasma pneumoniae IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055150 | Anti-Mycoplasma pneumoniae IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055167 | Anti-Mycoplasma pneumoniae IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055174 | Anti-Mycoplasma pneumoniae IFA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055181 | Anti-Mycoplasma pneumoniae IFA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055198 | Anti-Mycoplasma pneumoniae IFA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055204 | Anti-Mycoplasma pneumoniae IFA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016055211 | Anti-Mycoplasma pneumoniae IFA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016078449 | Anti-Mycoplasma pneumoniae IFA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |