W81K0223Q0027Attachment 1 Minimum Requirements_Amendment 0002.pdf

Item Number

1 FMH RAPID SCREEN

2 Anti-A (Mono) Ser, 10X10 mL

3 Anti-B, Mono Ser3, 1X10 mL

4 Anti-A,B 10X10 mL

5 Anti-D Mono Ser4, 10X10 mL

6 Bovine Albumin 22%, 10X10 mL

7 Gamma N-HANCE, 10X10 mL

8 Anti-IgG, -C3d M/P Grn 10X10 mL

9 Anti-Jka, Gamma-clone 1x5

10 Anti-IgG,C3d, M/P Grn 3X10 mL

11 Anti-E, Mono 1X5ml (Gammaclone)

12 Anti-A1 Lectin (Dolichos bifluorus), 1X5

13 Reference Cells A1, B, 2X10

14 Check cell

15 Pano screen I,II&III, 3X10

16 Pano scrren 16, 16X3

17 complement cooms control cell

18 RQC CORQC Test SYS KIT, 2X11.5

19 Anti-e(little), 1X5

20 Anti-s(Little), 1X5

21 Anti-Kpa, 1X2

22 Anti-Fyb, 1X5

23 Anti-Leb, 1X5

24 ANTI-C (BIG), 1X5

25 ANTI-c (little)

26 Anti-P1 Blood group Substance, 1X5

27 Anti-K(Kell), 1X5ml

28 Anti-k( Cellano) (Little), 1X5

29 Anti-Jkb, 1X5

30 Anti-S (big), 1X5

31 Anti-M, 1X5

32 Anti-N, 1X5

33 Anti-Lea, 1X5

34 Anti-C3b,C3d, 1X5

35 Elusion kit

Minimum Requirements :

1) Reagents shall be US FDA approved;

2) Shall be supplied prior to the expiration date which is approximately 10 months after production OR prior to depletion rate every 4 weeks;

3) Shall meet the US FDA criteria for specificity and potency with license number assigned, lot number, and expiration date placed on the label.

4) All reagents shall be stored at 2-8 degrees Celsius.

The following are minimum requirements for each reagent.

W81K0223Q0027 Attachment 1