LJZ · Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Microbiology · 21 CFR 866.3375 · Class 1
Overview
| Product Code | LJZ |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Regulation | 21 CFR 866.3375 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Mycoplasma spp. in serum. Additionally, some of these reagents consist of Mycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Mycoplasma and provides epidemiological information on diseases caused by these microorganisms. Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection with Mycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K984153 | THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. | Zeus Scientific, Inc. | Jan 11, 1999 | SESE |
| K971503 | MYCOPLASMA IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | Aug 20, 1997 | SESE |
| K971393 | MYCOPLASMA IGG ELISA TEST SYSTEM | Immunoprobe, Inc. | Jul 14, 1997 | SESE |
| K970150 | MYCOPLASMA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jun 16, 1997 | SESE |
| K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | Genbio | May 5, 1997 | SESE |
| K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | Genbio | May 2, 1997 | SESE |
| K934550 | IMMUNOCARD MYCOPLASMA | Meridian Diagnostics, Inc. | Sep 20, 1994 | SESE |
| K920212 | MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM | Shared Systems, Inc. | Aug 20, 1992 | SESE |
| K921556 | MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | Jun 29, 1992 | SESE |
| K904501 | MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | Feb 26, 1991 | SESE |
| K895276 | DIATECH IGM-MP TEST | Diatech Diagnostica , Ltd. | Dec 18, 1989 | SESE |
| K882596 | MP TEST | Diatech Diagnostica , Ltd. | Jun 21, 1989 | SESE |
| K823804 | MYCOPLASMELISA TEST KIT | M.A. Bioproducts | May 25, 1983 | SESE |
Top Applicants
- Zeus Scientific, Inc. — 3 clearances
- Diatech Diagnostica , Ltd. — 2 clearances
- Genbio — 2 clearances
- Medical Diagnostic Technologies, Inc. — 2 clearances
- Immunoprobe, Inc. — 1 clearance
