Manufacturer

R&D Systems

United StatesLegal entities : R&D Systems, Inc.

Markets : Finland · France · United States

Approvals : EU – class B · United States (FDA) – 510(k) : 79 · class I, II · latest in 2016 · see on the FDA website

EU representative : BIO-TECHNE SAS (France)

regulatorydiagnosticsdivision@bio-techne.com

7 categories, 96 models including 96 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Multilevel blood controls	W0103010503	3K Retic RETIC357 refs98/79 4K Retic RETIC37 refs98/79 ADVIA Retic Plus RETIC77 refs98/79 Body Fluid Control 0BF110VA298/79 Body Fluid Control 0BF220VA298/79 78 others Body Fluid Control 0BF330VA298/79 Body Fluid Control BF00198/79 Body Fluid Control BF00298/79 Body Fluid-I 0BI004TA398/79 Body Fluid-I 0BI022TA398/79 Body Fluid-I 0BI040TA398/79 Body Fluid-I 0BI111TA398/79 Body Fluid-I 0BI202TA398/79 Body Fluid-I 0BI220TA398/79 Body Fluid-I 0BI222TA398/79 Body Fluid-I 0BI330TA398/79 Body Fluid-I 0BI400TA398/79 Body Fluid-I BFI00198/79 Body Fluid-I BFI00298/79 Body Fluid-U ABF515 refs98/79 CBC-3D Plus CRP CBC-3D1C6 refs98/79 CBC-3D132 refs98/79 CBC-3K CBC-4K616 refs98/79 CBC-5D512 refs98/79 CBC-5DMR BC-5D314 refs98/79 CBC-7B21 refs98/79 CBC-DH DH-5D16 refs98/79 CBC-LINE CL00998/79 CBC-LINE CL01098/79 CBC-LINE CL01198/79 CBC-LINE CL01298/79 CBC-LINE CL01398/79 CBC-LINE CL01598/79 CBC-LINE CL01698/79 CBC-LINE CL01898/79 CBC-LINE CL01998/79 CBC-LINE CL02098/79 CBC-LINE CL02198/79 CBC-LINE CL02298/79 CBC-LINE CL02598/79 CBC-LINE CL02798/79 CBC-LINE CL02998/79 CBC-LINE CL03198/79 CBC-LINE CL03298/79 CBC-LINE CL03498/79 CBC-LINE CL03598/79 CBC-LINE CL03698/79 CBC-LINE CL03798/79 CBC-LINE for HemoCue98/79 CBC-LINE LINL398/79 CBC-LINE Ultra Low98/79 CBC-LINE Ultra Low Plus RBC98/79 CBC-PIX4 refs CBC-ST Plus ST222 refs98/79 CBC-SYS SF323 refs98/79 CBC-Tech T815 refs98/79 CBC-X X00298/79 CBC-X X00398/79 CBC-X X003X98/79 CBC-XE19 refs98/79 CBC-XN14 refs98/79 CBC-XR20 refs98/79 HC WBC Control3 refs98/79 HC WBC Diff Control4 refs98/79 HCT Extended 0EH110TA398/79 HCT Extended 0EH220TA398/79 HCT Extended 0EH400TA398/79 HCT Extended HCT00498/79 HGB Extended CBC-7B11 refs98/79 LeukoReduced Combo Kit LRPLT, LRRBC22 refs98/79 LeukoReduced PLT2 refs98/79 LeukoReduced RBC LRRBC22 refs98/79 Platelet-Trol Extended9 refs98/79 PLT-LINE98/79 R&D Retic-I5 refs RET-LINE B RETLINE398/79 Retic-I DxH-800 RETIC72 refs98/79 SEDRite III ESR22 refs98/79 SEDRite Plus ESR222 refs98/79 SYSXR98/79 T898/79 XE-nRBC12 refs98/79 XERet13 refs98/79	B IVDR, 98/79	EUDAMED record Report an error
Abnormal blood controls	W0103010502	Sickle QC Control 0SC110VA298/79 Sickle QC Control 0SC220VA298/79 Sickle QC Control SQC00198/79 Sickle QC Control SQC00298/79	– 98/79	EUDAMED record Report an error
Whole blood calibrators	W0103010507	CBC-CAL PLUS NCAL12 refs R&D Retic2 refs Tech-Cal4 refs	B IVDR	EUDAMED record Report an error
Haematology controls - other	W0103010599	FETALtrol HGBF215 refs98/79 Glu/Hgb Control HEGLU216 refs98/79	– 98/79	EUDAMED record Report an error
Lymphocyte subtyping controls	W0103080403	StatusFlow WBFC210 refs98/79 StatusFlowLo WBFCD4Lo5 refs98/79	– 98/79	EUDAMED record Report an error
Normal blood controls	W0103010501	CBC-3K CBC-4K63 refs98/79	– 98/79	EUDAMED record Report an error
Stem cell enumeration controls	W0103080404	StatusFlowPro WBFC23410 refs98/79	– 98/79	EUDAMED record Report an error

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