LIAPHEN™ line
CE-IVD 120002 ........................................... p.38 CE-IVD 120003 ........................................... p.39 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, 59, 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, 56, 58 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.48, 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, 58, 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, 84, 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, 67, 85 CE-IVD 223602 .................................p.43, 114 CE-IVD 223605 .................................p.43, 114 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, 57, 66, 84, 100 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.56-58, 66, 84 RUO 224601 ......... p.48, 51, 81, 99, 106 CE-IVD 224701 ....................p.56, 60, 67, 85 RUO 224801 ......... p.48, 51, 81, 99, 106 CE-IVD 224901 ........................... p.49, 51, 80 CE-IVD 225001 ....................p.56, 60, 67, 85 CE-IVD 225101 .................... p.56-58, 66, 84 CE-IVD 225201 .................... p.56-58, 67, 85 CE-IVD 225301 .................... p.56-58, 66, 84 CE-IVD 225401 .................... p.56-58, 67, 85 CE-IVD 225501 .................... p.56-58, 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, 58, 64, 82 CE-IVD 226101 ............p.55, 57, 58, 64, 82 CE-IVD 226201 ............p.55, 57, 58, 64, 82 CE-IVD 226301 ........................... p.49, 50, 80 CE-IVD 226401 ............p.55, 57, 58, 65, 83 CE-IVD 226501 ............p.55, 57, 58, 65, 83
Regulatory Status Reference Page Regulatory Status Reference PageRegulatory Status Reference Page Regulatory Status Reference Page
CE-IVD 226601 ....................p.12, 13, 15, 79 CE-IVD 226701 ....................p.55, 60, 65, 83 CE-IVD 227005 ................................... p.25, 33 CE-IVD 227102 ................................... p.25, 26 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.109 RUO AR004K .............................p.102, 110 RUO AR005A - K - L ................p.102, 110 RUO AR006K .............................p.102, 110 RUO AR008K .............................p.102, 111 RUO AR010A ..............................p.104, 113 RUO AR011K .............................p.105, 113 RUO AR013A ..............................p.104, 113 RUO AR015A ..............................p.103, 111 RUO AR015B .............................p.103, 112 CE-IVD AR021B - K - L - M - N ........... p.109 RUO AR022A ..............................p.104, 112 CE-IVD AR026A - K ................................. p.109 RUO AR028K .............................p.102, 110 RUO AR029K .............................p.103, 112
RUO AR030K .............................p.103, 111 RUO AR031K .............................p.103, 111 CE-IVD AR032A - K .................p. 56, 60, 109 RUO AR103A ..............................p.104, 112 RUO AR104A ..............................p.104, 113
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 CE-IVD CK584K - L ............................ p.12, 25 CE-IVD CK586K - L ............................ p.12, 25
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