FDA.reportPublic FDA data

EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]

Primary DI
00083059070255
Brand
EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]
Company
BIOMERICA, INC.
Model
7025
Device description
The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGTAssay, Erythropoietin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGTAssay, ErythropoietinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992799000SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITSangui Biotech, Inc.2000-06-07GGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083059070255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083059070255000830590702550830590702550083059070255

GMDN Terms#

Term, Definition table
TermDefinition
Erythropoietin (EPO) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of erythropoietin (EPO) in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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08305900070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]70242016-12-07
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08305900070309Myoglobin Enzyme Immunoassay Test Kit70302016-12-07
08305900070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT70312016-12-08
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474036466EPO (Erythropoietin) ELISADRG Instruments Gesellschaft mit beschränkter HaftungGGT2023-08-31
00630414010380ADVIA Centaur EPOSiemens Healthcare Diagnostics Inc.GGT2019-11-18
00630414245775Atellica IM EPOSiemens Healthcare Diagnostics Inc.GGT2019-11-18
00840239036469EPO (Erythropoietin) ELISADRG International IncGGT2019-06-06
B24221EPOHUE010Erythropoietin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.GGT2017-08-03
08305900070255EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.GGT2016-12-07
15099590201838Access EPOBeckman Coulter, Inc.GGT2016-08-26
10815762021685Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.GGT2016-07-29
00815762021640Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.GGT2016-07-29
00815762021671Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.GGT2016-07-29