FDA.reportPublic FDA data

EPO (Erythropoietin) ELISA

Primary DI
04048474036466
Brand
EPO (Erythropoietin) ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-3646
Catalog number
EIA-3646
Device description
The EPO ELISA is intended for in vitro diagnostic use in the quantitative determination of Erythropoietin (EPO) in human serum
Published
2023-08-31
Public version status
New
Distribution status
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
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
04048474036466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474036466040484740364664048474036466

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.

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
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00083059070255EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.GGT2020-07-01
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