FDA.reportPublic FDA data

Research and Diagnostic Systems

Primary DI
10815762020930
Brand
Research and Diagnostic Systems
Company
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Model
3KC11
Catalog number
3KC11
Device description
CD-Cal (Calibrator): 2 x 3mL
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
KRXCalibrator For Cell Indices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRXCalibrator For Cell IndicesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003991000CD-CAL PLUS CALIBRATORR&D Systems, Inc.2001-01-16KRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815762020930PrimaryGS10
00815762020933Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081576202093010815762020930
00815762020933008157620209338157620209330815762020933

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume6Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-428-4246customerserviceccd@bio-techne.com

Regulatory Flags#

DUNS number
087248183
Device count
2
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
00815762023446Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2025-12-01
00815762023453Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2025-12-01
06936415992927SC-CAL PLUSShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2025-01-17
00380740151294AlinityAbbott GmbHKRX2023-11-16
14987562460332XN CALSYSMEX CORPORATIONKRX2017-10-06
14987562460356XN CAL PFSYSMEX CORPORATIONKRX2017-10-06
14987562460592X-CAL CalibratorSYSMEX CORPORATIONKRX2017-10-06
D757U2260K1One Step Plus KITBISCO INC.KRX2017-06-12
15099590639426COULTER AcTBeckman Coulter, Inc.KRX2016-09-23
06944904084152SC-CAL PLUS CalibratorShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2016-09-23
20844509000314Cal-Chex A Plus STRECK, INC.KRX2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRX2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KRX2016-09-16
00817274020258Drew ScientificDREW SCIENTIFIC, INC.KRX2016-09-09
00380740119843CELL-DYNABBOTT LABORATORIESKRX2016-09-09
00812137010254CDS-LTX CONTROLCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRX2016-09-08
00856605006004MINOCALHORIBA INSTRUMENTS INCORPORATEDKRX2016-08-10
00856605006103MINOCALHORIBA INSTRUMENTS INCORPORATEDKRX2016-08-10
14987562460325XN CALSYSMEX CORPORATIONKRX2016-08-04
14987562460349XN CAL PFSYSMEX CORPORATIONKRX2016-08-04
14987562460585X-CAL CalibratorSYSMEX CORPORATIONKRX2016-08-04
10815762020473Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762020503Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762020541Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762021166Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
20815762020470Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
20815762020937Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
30815762020477Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
00815762020483Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
00380740017071CELL-DYNABBOTT LABORATORIESKRX2016-06-06