FDA.reportPublic FDA data

Autostat II IgA Rheumatoid Factor

Primary DI
00816879020069
Brand
Autostat II IgA Rheumatoid Factor
Company
HYCOR BIOMEDICAL LLC
Model
FGA06
Catalog number
FGA06
Device description
96 well ELISA for the detection of IgA Rheumatoid Factor antibodies in human serum.
Published
2018-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K993557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993557000AUTOSTAT II RHEUMATOID FACTOR IGA ELISACogent Diagnotics , Ltd.2000-03-03DHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020069008168790200698168790200690816879020069

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-382-2527Customerservices-us@hycorbiomedical.com

Regulatory Flags#

DUNS number
010558476
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00810053950463NOVEOS Ara h 2, PeanutF423C63274-3Z2026-07-29
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00816879027341NOVEOS Hazelnut, Corylus avellanaF017632322026-07-29
00816879027969NOVEOS Almond, Amygdalus communisF02086340402026-07-29

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