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Legionella pneumophila IgG ELISA

FDA UDI

Class II (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
Legionella pneumophila IgG ELISA FDA UDI
Generic Name
Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control FDA UDI
Device Name
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin). FDA UDI
Model / Reference
EIA-5645 FDA UDI
Description
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin). FDA UDI

Identifiers

Catalog Number
EIA-5645 FDA UDI
Primary DI / UDI-DI
04048474056457 FDA UDI
FDA Product Code
MJH FDA UDI
GMDN Term
Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3300 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

No

FDA UDI

Category: Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Legionella pneumophila IgG ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control.

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 550dc24b-153c-4255-b758-271f80cc0600 36 fields · synced Jun 1, 2026