FDA.reportPublic FDA data

Erythropoietin ELISA

Primary DI
B24221EPOHUE010
Brand
Erythropoietin ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
21-EPOHU-E01
Catalog number
21-EPOHU-E01
Device description
The EPO ELISA is intended for use in 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.
Published
2017-08-03
Public version status
Update
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
B24221EPOHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of erythropoietin (EPO) in a clinical specimen, using a chemiluminescent immunoassay 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
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B24280LACHUFC9000ALPCO Lactoferrin CLIA Kit80-LACHU-FC90080-LACHU-FC9002026-03-31
B24230PANHUE010Pancreatic Elastase ELISA30-PANHU-E0130-PANHU-E012020-07-17
B24280EZDEV21000Unfilled Easy 2 Stool Extraction Device80-EXDEV2-10080-EXDEV2-1002026-02-02
B24280EZEX21000Easy 2 Stool Extraction Device80-EZEX2-10080-EZEX2-1002025-10-30
B24280CALPHUCH500ALPCO Calprotectin Chemiluminescence ELISA80-CALPHU-CH5080-CALPHU-CH502019-11-04
B24224MABHUE010Microalbumin ELISA24-MABHU-E0124-MABHU-E012018-01-16
B24280LACHUFCSET0Lactoferrin CLIA Re-Calibrator and Control Set80-LACHU-FCSET2025-06-06
B24280PANHUFCSET0Pancreatic Elastase CLIA Re-Calibrator and Control Set80-PANHU-FCSET2025-06-06
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)25-TT4HU-E0125-TT4HU-E012017-08-03
B24211PREHUE010Pregnenolone ELISA11-PREHU-E0111-PREHU-E012020-09-25
B24280PANHUCH500Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH5080-PANHU-CH502022-09-09
B24280LACHUFC1000ALPCO Lactoferrin CLIA Kit80-LACHU-FC10080-LACHU-FC1002025-03-03
B24211HGHHUE010Human Growth Hormone ELISA11-HGHHU-E0111-HGHHU-E012025-01-20
B24280PANHUFC1000ALPCO Pancreatic Elastase CLIA80-PANHU-FC10080-PANHU-FC1002024-07-25
B24280PANHUCH010Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH0180-PANHU-CH012022-09-09
B24211GLUHUE010Glucagon ELISA11-GLUHU-E0111-GLUHU-E012024-10-23
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISA20-TT3HU-E0120-TT3HU-E012024-07-22
B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT20080-CALPHU-IT2002023-08-18
B24280CALPHUITCAL0Calprotectin Immunoturbidimetric Assay - Calibrators80-CALPHU-ITCAL80-CALPHU-ITCAL2023-08-18
B24280CALPHUITCON0ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-ITCON80-CALPHU-ITCON2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474036466EPO (Erythropoietin) ELISADRG Instruments Gesellschaft mit beschränkter HaftungGGT2023-08-31
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
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