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RF IgM (Rheumatoid Factor) ELISA

FDA UDI

Class II (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
RF IgM (Rheumatoid Factor) ELISA FDA UDI
Generic Name
Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM-class antibody in human sera. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis. FDA UDI
Model / Reference
EIA-2775 FDA UDI
Description
The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM-class antibody in human sera. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis. FDA UDI

Identifiers

Catalog Number
EIA-2775 FDA UDI
Primary DI / UDI-DI
04048474027754 FDA UDI
510(k) Number
K961277 FDA UDI
FDA Product Code
DHR FDA UDI
GMDN Term
Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5775 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 30 Milliliter FDA UDI
Total Volume — 100 Milliliter FDA UDI
Total Volume — 15 Milliliter FDA UDI
Total Volume — 0.5 Milliliter FDA UDI
Total Volume — 0.35 Milliliter FDA UDI

RF IgM (Rheumatoid Factor) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID

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 9d884d8f-fe52-4c66-bfce-b315044c35ac 38 fields · synced May 29, 2026