RSV IgG Elisa

The DRG RSV IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Respiratory Syncytial Virus (RSV) in serum.

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code MCE
Manufacturer City Province Registered as Device types
Yiwu Daqida Plastic Products Co., Ltd. Yiwu Zhejiang Repacker / relabeller 9

Record

Regulatory record for RSV IgG Elisa
Listed by DRG International, Inc., United States
FDA product code MCE
Device type Respiratory Syncytial Virus – Elisa
Device class Class 1
Regulation 21 CFR 866.3480
Establishment Repacker / relabeller, Complaint-file establishment
Premarket notification Exempt
Record published 2023-08-24

Specifications

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

Catalogue Numbers

Catalogue numbers for RSV IgG Elisa
Catalogue number Size Status
EIA-3057 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RSV IgG Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2
Anti-RSV Elisa (IgM) Euroimmun Medizinische Labordiagnostika AG 1
NovaLisa Respiratory Syncytial Virus IgG Gold Standard Diagnostics Frankfurt GmbH 1
Anti-RSV Elisa (IgG) Euroimmun Medizinische Labordiagnostika AG 1
QuickVue Quidel Corp. 1
Anti-RSV Elisa (IgA) Euroimmun Medizinische Labordiagnostika AG 1

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer