FDA.reportPublic FDA data

MERIFLUOR GullSORB

Primary DI
00840733101304
Brand
MERIFLUOR GullSORB
Company
MERIDIAN BIOSCIENCE, INC.
Model
XX715
Catalog number
XX715
Device description
GullSORB is an antihuman IgG reagent used to eliminate IgG interference in human serum containing both IgM and IgG. This reagent has been standardized for use with IgM IFA assays manufactured by Meridian Bioscience, Inc.
Published
2016-09-23
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
DEWIgg, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEWIgg, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K875254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875254000GULLSORB IGG INACTIVATION REAGENTGull Laboratories, Inc.1988-02-17DEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101304008407331013048407331013040840733101304

GMDN Terms#

Term, Definition table
TermDefinition
Human immunoglobulin G (IgG) caprine conjugate antibody reagent IVDOne or multiple caprine immunoglobulins (sourced from a goat) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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