Mycoplasma Hominis IgG Elisa
The DRG Mycoplasma hominis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Mycoplasma hominis in serum and…
The DRG Mycoplasma hominis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Mycoplasma hominis in serum and plasma.
Who Else Makes It
Concentrated in Jilin (1), Hebei (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
Record
| Listed by | DRG International, Inc., United States |
|---|---|
| FDA product code | CDX |
| Device type | Radioimmunoassay, Total Thyroxine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1700 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2023-08-25 |
| Record revised | 2023-11-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2023-11-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-4559 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elecsys T4 | Roche Diagnostics Gmbh | 3 |
| Total T4 MAb 125I RIA Kit | Mp Biomedicals, LLC | 3 |
| Advia Centaur® T4 | Siemens Healthcare Diagnostics Inc | 2 |
| AutoDELFIA Neonatal Thyroxine (T4) kit | Wallac OY | 2 |
| Elecsys CalSet T4 | Roche Diagnostics Gmbh | 1 |
| T4 AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| Atellica IM T4 DIL | Siemens Healthcare Diagnostics Inc | 1 |
| N-T4 AccuBind Elisa Test System – 960 Wells | Monobind, Inc. | 1 |
| N-T4 AccuBind Elisa Test System – 480 Wells | Monobind, Inc. | 1 |
| N-T4 AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| T4 SBS AccuLite Clia Test System – 192 Wells | Monobind, Inc. | 1 |
| iFlash-T4 | Shenzhen Yhlo Biotech Co., Ltd. | 1 |
Showing 12 of 31. All products under Radioimmunoassay, Total Thyroxine
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-06-04 | Class III | Reprocessing Controls | An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). T | 47 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.