Anisakidae IgG Elisa
The Anisakidae ELISA test is a qualitative enzyme immunoassay for the detection of Anisakidae antibodies in human serum samples.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Zhejiang Runlab Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | Bordier affinity products S.A. |
|---|---|
| FDA product code | LIB |
| Device type | Device, General Purpose, Microbiology, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Premarket notification | Exempt |
| Record published | 2022-10-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature -20 to 37 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 45 |
| Caplugs/Evergreen | Caplugs, Inc. | 28 |
| Device, General Purpose, Microbiology, Diagnostic | Scientific Device Laboratory, Inc. | 21 |
| Globe Scientific | Globe Scientific, LLC | 20 |
| Medline | Medline Industries, Inc. | 15 |
| Parasite Suspensions | Microbiologics, Inc. | 12 |
| Inoculating Loop | Zhejiang Runlab Technology Co., Ltd. | 4 |
| Planet-Safe® | Diversified Biotech, Inc. | 4 |
| Device, General Purpose, Microbiology, Diagnostic | Hardy Diagnostics | 4 |
| Inoculating Loop Typenex | Zhejiang Runlab Technology Co., Ltd. | 4 |
| MicroScan | Beckman Coulter, Inc. | 3 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 2 |
Showing 12 of 64. All products under Device, General Purpose, Microbiology, Diagnostic
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.