FDA.reportPublic FDA data

RF IgM (Rheumatoid Factor) ELISA

Primary DI
00840239027757
Brand
RF IgM (Rheumatoid Factor) ELISA
Company
DRG International Inc
Model
EIA-2775
Catalog number
EIA-2775
Device 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.
Published
2019-03-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DHRSYSTEM, TEST, RHEUMATOID FACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHRSystem, Test, Rheumatoid FactorImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961277000RF IGM ELISA TEST SYSTEMZeus Scientific, Inc.1996-05-08DHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239027757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239027757008402390277578402390277570840239027757

GMDN Terms#

Term, Definition table
TermDefinition
Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.35Milliliter
Total Volume0.5Milliliter
Total Volume15Milliliter
Total Volume30Milliliter
Total Volume100Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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Primary DI, Brand, Company table
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