FDA.reportPublic FDA data

Research and Diagnostic Systems

Primary DI
00815762021671
Brand
Research and Diagnostic Systems
Company
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Model
CEP01
Catalog number
CEP01
Device description
Quantikine Erythropoietin Control 1 & 2 (5 vials of each)
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K931756000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931756000QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLSR&D Systems, Inc.1994-04-21GGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815762021671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815762021671008157620216718157620216710815762021671

GMDN Terms#

Term, Definition table
TermDefinition
Erythropoietin (EPO) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of erythropoietin (EPO) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-70 Degrees Celsius-20 Degrees Celsius
Storage Environment Temperature-70 Degrees Celsius-20 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-343-7475techsupport@bio-techne.com

Regulatory Flags#

DUNS number
087248183
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
00815762021183Research and Diagnostic SystemsPTE004PTE0042016-07-29
00815762021923Research and Diagnostic SystemsPTE5XPTE5X2016-09-13
00815762021930Research and Diagnostic SystemsPTE4XPTE4X2016-09-13
00815762021947Research and Diagnostic SystemsPTE6XPTE6X2016-09-13
00815762021954Research and Diagnostic SystemsPTE3XPTE3X2016-09-13
00815762021190Research and Diagnostic SystemsPTE006PTE0062016-07-29
00815762020490Research and Diagnostic SystemsPIX0022025-12-01
00815762023446Research and Diagnostic Systems0CP010TA32025-12-01
00815762023453Research and Diagnostic Systems0CP020TA32025-12-01
00815762021657Research and Diagnostic SystemsDTFR1DTFR12016-07-29
00815762021718Research and Diagnostic SystemsRDKAP1971RDKAP19712016-09-01
00815762021978R & D Systems, Inc. CBC-PIX Hematology ControlP0022018-12-05
00815762020131Research and Diagnostic Systems3D5043D5042016-12-20
00815762020148Research and Diagnostic Systems3D5053D5052016-12-20
00815762020155Research and Diagnostic Systems3D505T3D505T2016-12-20
00815762020223Research and Diagnostic Systems3D5183D5182016-12-20
00815762021145Research and Diagnostic SystemsLH002LH0022016-07-29
00815762021152Research and Diagnostic SystemsLH004LH0042016-07-29
00815762021282Research and Diagnostic SystemsRP401RP4012016-07-29
00815762021299Research and Diagnostic SystemsRP403RP4032016-07-29

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
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