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RSV IgG ELISA

FDA UDI

Class I (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
RSV IgG ELISA FDA UDI
Generic Name
Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
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. FDA UDI
Model / Reference
EIA-3507 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
EIA-3507 FDA UDI
Primary DI / UDI-DI
04048474035070 FDA UDI
FDA Product Code
MCE FDA UDI
GMDN Term
Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3480 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

RSV IgG ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG Instruments Gesellschaft mit beschränkter Haftung

Sources (1)

  • FDA UDI 850fc60d-0594-4cfa-bdf0-e59fc300cf5f 36 fields · synced May 30, 2026