FDA.reportPublic FDA data

R & D Systems, Inc. CBC-PIX Hematology Control

Primary DI
00815762021978
Brand
R & D Systems, Inc. CBC-PIX Hematology Control
Company
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Model
P002
Device description
CBC-PIX Hematology Control
Published
2018-12-05
Public version status
Update
Distribution status
Not 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
JCNControl, Cell Counter, Normal And Abnormal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCNControl, Cell Counter, Normal And AbnormalHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815762021978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815762021978008157620219788157620219780815762021978

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of 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, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-656-4501alicia.felthauser@bio-techne.com

Regulatory Flags#

DUNS number
087248183
Device count
1
Premarket exempt
true
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
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
00815762021961Research and Diagnostic Systems72000720002016-09-20

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Primary DI, Brand, Company table
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00630414224404ADVIA® 120/2120/2120i TESTpoint High ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473390ADVIA® 120/2120/2120i 3-in-1 TESTpoint Normal ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473406ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473413ADVIA® 120/2120/2120i 3-in-1 TESTpoint High ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
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