RF IgM (Rheumatoid Factor) ELISA EIA-2775

GUDID 00840239027757

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 International Inc

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	00840239027757
NIH Device Record Key	8d326dd7-70bf-4846-8650-d341f0edf88c
Commercial Distribution Status	In Commercial Distribution
Brand Name	RF IgM (Rheumatoid Factor) ELISA
Version Model Number	EIA-2775
Catalog Number	EIA-2775
Company DUNS	075150847
Company Name	DRG International Inc
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	false
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
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239027757 [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	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-03-30
Device Publish Date	2019-03-20

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