RF IgM (Rheumatoid Factor) ELISA EIA-2775

GUDID 04048474027754

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.

DRG Instruments Gesellschaft mit beschränkter Haftung

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04048474027754
• NIH Device Record Key: 9d884d8f-fe52-4c66-bfce-b315044c35ac
• Commercial Distribution Discontinuation: 2024-11-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RF IgM (Rheumatoid Factor) ELISA
• Version Model Number: EIA-2775
• Catalog Number: EIA-2775
• Company DUNS: 317134468
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com

Device Dimensions

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• Total Volume: 30 Milliliter
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• Device Size Text, specify: 0
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• Total Volume: 30 Milliliter
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Total Volume: 30 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 15 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Total Volume: 0.5 Milliliter
• Total Volume: 0.35 Milliliter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048474027754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961277

FDA Product Code

• DHR: SYSTEM, TEST, RHEUMATOID FACTOR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-02
• Device Publish Date: 2024-11-22

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