# Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) (Text with EEA relevance) (2002/364/EC), Division 1: Test reagents

Extent: E+W+S+N.I.

Only by recommended techniques where reactivity against these antigens is claimed.
Note: Polyclonal reagents must be tested against a wider panel of cells to confirm specificity and exclude presence of unwanted contaminating antibodies.
Blood group reagents
Minimum number of control cells to be tested
Positive reactions
Negative reactions
A1
A2B
Ax
B
0
Anti-ABO1 (anti-A)
2
2
2
2
2
B
A1B
A1
0
Anti-ABO2 (anti-B)
2
2
2
2
A1
A2
Ax
B
0
Anti-ABO3 (anti-A,B)
2
2
2
2
4
R1r
R2r
WeakD
r’r
r’r
rr
Anti-RH1 (anti-D)
2
2
2
1
1
1
R1R2
R1r
r’r
R2R2
r’r
rr
Anti-RH2 (anti-C)
2
1
1
1
1
1
R1R2
R1r
r’r
R1R1
Anti-RH4 (anti-c)
1
2
1
3
R1R2
R2r
r’r
R1R1
r’r
rr
Anti-RH 3 (anti-E)
2
1
1
1
1
1
R1R2
R2r
r’r
R2R2
Anti-RH5 (anti-e)
2
1
1
3
Kk
kk
Anti-KEL1 (anti-K)
4
3

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Source: https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/10/division/1 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-10/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.