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MERIFLUOR GullSORB

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
MERIFLUOR GullSORB FDA UDI
Generic Name
Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
XX715 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
XX715 FDA UDI
Primary DI / UDI-DI
00840733101304 FDA UDI
510(k) Number
K875254 FDA UDI
FDA Product Code
DEW FDA UDI
GMDN Term
Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

MERIFLUOR GullSORB by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI c03465b9-fa13-4cf4-8b86-19a0110473ef 38 fields · synced May 30, 2026