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LIAPHEN™ line
CE-IVD 120002 ........................................... p.38 CE-IVD 120004 ........................................... p.40 CE-IVD 120008 ........................................... p.38 CE-IVD 120102 ........................................... p.14 CE-IVD 120206 ................................... p.21, 28
BIOPHEN™ line
RUO 220005 .................p.55, 56, 58, 100 CE-IVD 220202 ........................... p.55, 56, 60 RUO 220412 ................................... p.48, 99 CE-IVD 220502 ........................................... p.72 CE-IVD, 510(k) 221003 ........................... p.55, 56, 59 RUO 221005 .................p.55, 56, 58, 100 CE-IVD, 510(k) 221006 .......................... p. 55, 56, 59 RUO 221007 .................p.55, 56, 58, 100 CE-IVD 221011 .................................... p.55-57 CE-IVD 221013 .................................... p.55-57 CE-IVD 221015 .................................... p.55-57 RUO 221020 .................................p.59, 100 CE-IVD 221030 .................................... p.55-57 CE-IVD, 510(k) 221102 ........................................... p.37 CE-IVD, 510(k) 221105 ........................................... p.37 CE-IVD 221111 ........................................... p.37 CE-IVD 221122 ........................................... p.38 CE-IVD 221123 ........................................... p.37 CE-IVD 221127 ........................................... p.37 CE-IVD, 510(k) 221205 ........................................... p.39 CE-IVD 221211 ........................................... p.39 RUO 221304 ........................... p.25, 30, 94 RUO 221312 ................................... p.49, 99 CE-IVD 221402 ................................... p.25, 26 CE-IVD 221406 ................................... p.25, 26 CE-IVD 221511 ........................................... p.72 RUO 221705 ........................... p.25, 31, 94 CE-IVD 221801 ................................... p.25, 27 CE-IVD 221802 ................................... p.25, 27 CE-IVD 221806 ................................... p.25, 27 RUO 221812 ................................... p.49, 99 CE-IVD, 510(k) 222001 .. p.55, 57-59, 64, 82, 100 CE-IVD, 510(k) 222101 ............p.13-15, 21, 26-32, .......... 34, 37-40, 50, 72, 75, 79, 94 CE-IVD 222201 ............p.55, 57, 59, 65, 83
CE-IVD, 510(k) 222301 .. p.55, 57-59, 64, 82, 100 CE-IVD, 510(k) 222401 ........................... p.41, 50, 80 CE-IVD 222501 .. p.55, 57-59, 64, 82, 100 CE-IVD 222701 ....................p.55, 57, 64, 82 CE-IVD 222801 ....................p.55, 60, 65, 83 CE-IVD 222901 ....................p.55, 60, 65, 83 CE-IVD, 510(k) 223001 ..................p.56-59, 66, 100 CE-IVD, 510(k) 223101 ..................p.56-59, 66, 100 CE-IVD, 510(k) 223201 ............p.12-15, 21, 26-32, .......... 34, 37-43, 51, 72, 75, 79, 94 CE-IVD, 510(k) 223301 ............p.12-15, 21, 26-32, .......... 34, 37-42, 51, 72, 75, 79, 94 CE-IVD, 510(k) 223405 ........................... p.41, 51, 80 CE-IVD 223501 ............p.56, 57, 59, 67, 85 CE-IVD 223602 .................................p.43, 117 CE-IVD 223605 .................................p.43, 117 CE-IVD, 510(k) 223701 ..........p.56-59, 66, 84, 100 CE-IVD, 510(k) 223801 ............p.56, 57, 59, 66, 84 CE-IVD, 510(k) 223901 ............p.56, 57, 59, 66, 84 CE-IVD 224001 .................... p.56-59, 66, 84 CE-IVD, 510(k) 224101 ............p.56, 57, 59, 66, 84 CE-IVD, 510(k) 224201 ............p.56, 57, 59, 66, 84 CE-IVD, 510(k) 224301 ............p.56, 57, 59, 66, 84 CE-IVD, 510(k) 224401 ............p.56, 57, 59, 66, 84 CE-IVD 224501 ....................p.56, 57, 66, 84 RUO 224601 ......... p.49, 51, 81, 99, 107 CE-IVD 224701 ....................p.56, 60, 67, 85 RUO 224801 ......... p.48, 51, 81, 99, 107 CE-IVD 224901 ........................... p.49, 51, 80 CE-IVD 225001 ....................p.56, 60, 67, 85 CE-IVD 225101 ....................p.56, 57, 66, 84 CE-IVD 225201 ....................p.56, 57, 67, 85 CE-IVD 225301 ....................p.56, 57, 66, 84 CE-IVD 225401 ....................p.56, 57, 67, 85 CE-IVD 225501 ....................p.56, 57, 67, 85 CE-IVD 225601 .............p.12-15, 42, 51, 79 CE-IVD 225701 ....................p.56, 60, 67, 85 CE-IVD 226001 ....................p.55, 57, 64, 82 CE-IVD 226101 ........................... p.55, 57, 64 CE-IVD 226201 ........................... p.55, 57, 64 CE-IVD 226301 ........................... p.49, 50, 80 CE-IVD 226401 ....................p.55, 57, 65, 83 CE-IVD 226501 ....................p.55, 57, 65, 83 CE-IVD 226601 .............p.12-15, 42, 50, 79
Regulatory Status Reference Page Regulatory Status Reference PageRegulatory Status Reference Page Regulatory Status Reference Page
CE-IVD 226701 ....................p.55, 60, 65, 83 CE-IVD 227005 ................................... p.25, 33 RUO 229001 - C..................................... p.92 RUO 229005 ........................................... p.92 RUO 229011 ........................................... p.92 RUO 229014 - C..................................... p.92 RUO 229015 ........................................... p.92 RUO 229021 ........................................... p.92 RUO 229031 ........................................... p.92 RUO 229041 ........................................... p.92 RUO 229061 ........................................... p.92 RUO 229091 ........................................... p.92
ZYMUPHEN™ line
RUO 521096 ................................... p.47, 98 RUO 521196 ................................... p.47, 98 RUO 521296 .................................p.74, 101
Aggregometry line
CE-IVD AG001K .......................................... p.20 CE-IVD AG002K .......................................... p.20 CE-IVD AG003K .......................................... p.20 CE-IVD AG004K .......................................... p.21 CE-IVD AG005K .......................................... p.20 CE-IVD AG006K .......................................... p.21
Auxiliary reagents
CE-IVD AR001B - K - L .......................... p.111 RUO AR004K .............................p.102, 111 RUO AR005A - K - L ................p.102, 112 RUO AR006K .............................p.102, 112 RUO AR007K .............................p.102, 112 RUO AR008K .............................p.103, 113 RUO AR009K .............................p.103, 113 RUO AR010A ..............................p.105, 116 RUO AR011K .............................p.105, 116 RUO AR012A ..............................p.105, 117 RUO AR013A ..............................p.105, 116 RUO AR015A ..............................p.103, 113 RUO AR015B .............................p.104, 114 CE-IVD AR021B - K - L - M - N ........... p.111 RUO AR022A ..............................p.104, 115 RUO AR024A ..............................p.105, 116 CE-IVD AR026A - K ................................. p.111 RUO AR027A ..............................p.106, 117
RUO AR028K .............................p.102, 112 RUO AR029K .............................p.104, 114 RUO AR030K .............................p.103, 113 RUO AR031K .............................p.103, 114 CE-IVD AR032A - K .................p. 56, 59, 114 RUO AR103A ..............................p.104, 115 RUO AR104A ..............................p.104, 115
Bovine Enzymes
RUO BE101D - L .................................... p.91 RUO BE102A - C - K ............................. p.91
HEMOCLOT™ line
CE-IVD CK002K - L .................... p.55, 56, 60 CE-IVD CK011K - L .................................... p.14 CE-IVD CK012K .......................................... p.14 CE-IVD CK031K .......................................... p.38 CE-IVD CK032K .......................................... p.38 CE-IVD CK041K .......................................... p.40 CE-IVD CK042K .......................................... p.40 CE-IVD CK051K - L ............................ p.25, 30 CE-IVD, 510(k) CK065K .......................................... p.41 CE-IVD CK090K .......................................... p.42 CE-IVD CK091K .......................................... p.43 CE-IVD CK092K .......................................... p.49 CE-IVD CK094K .......................................... p.42
CEPHEN™ line
CE-IVD CK511K .......................... p.12, 25, 42 CE-IVD CK512K .......................... p.12, 25, 42 CE-IVD CK515K - L .................... p.12, 25, 42 CE-IVD CK521K .................................. p.13, 42 CE-IVD CK522K .................................. p.13, 42
FIBRIPHEN™ line
CE-IVD CK571K .......................................... p.13 CE-IVD CK572K .......................................... p.13 CE-IVD CK575K .......................................... p.13 CE-IVD CK585K .......................................... p.13
PT-phen™ line
CE-IVD CK581 ..................................... p.12, 25 CE-IVD CK582 ..................................... p.12, 25 CE-IVD CK583 ..................................... p.12, 25