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&BD BBL™ Taxo™ INH Test Strips and Control “-T7 C € LO001520JAA(02) --3 2015-04 tact ju. ecu: BD representebve fr umsteuctions. | Ce. patve cee mecTHAn Bea TAM 2 Ma BL va WHvey Shi. | Pokyny van Peseytne in sin Z8-tup © spore-nc_ti BD. Konta.tt den lokale Bc) .€3)_semant for a. 48 insfrekticner. / Etc Ji +i ge TOV Tolk6 UTI BS. uNTS 46 ED 20 OGNyice. . “lasuius;uhiste suntes Kentukteeruge oma korain= BJ esinda,.ga. / Uta yhteys iah'inp .an BD:n edust_jaan objeicen saamisexsi. | Aontak@raj lokalnog pretstevnik? BD 1a u_-vte. | A hatenziatt utasitast ker es BD hely! k.pviseletetél. | Hyckaynap it kep.inikts BD 8.cnimex .auap acuHbis./ca’ sa_emtu noradjumus sa-iniefes ar vietejo BD purstav:. / Naudojino instrukc’j. teiraukités vetos BD jgaliotojo atstovo. | Neen: contact op met uw plastselijke BD vertegenwoord'ger voor instructies, ! Kontakt din lokale BO representant for mer informasjon. / Aby uzyskaé: instrukeje u_ytko..an‘a, skontaktuj sig z lokalnym przedstav.icielstwem BD. / Contacte 0 representante local da BD para instrug“es. / Pentru instructiuni, contactati reprezentantul local BD. / nw nony4eHue ykasanwa oupaTHTece K MeCTHOMy «ipeAcTasMiento KoMMaK:::: BD. / :nétrukcie ziskate u miestneho zastupcu spolognosti BD. / Obratite se svom lokainom predstavniku kompanije BD za uputstva. / Kontakta nérmaste BD-representant fér anvisningar, ! Talimatlar icin yere! BD temsilcinizle temasa gegin. | 3a inerpykjinma SBepnizeca go Micuesoro npeAcTasHMna Kownanil BD. I4dTENDED USE Bi) BBL™ Taxo-™ N.4 Tes: drips <7e used fo. deiec:ing isuri Metdvoies in sine BD BBL T-xo Nd test Contro is used as a positive controi for NH Tesi St“ps. pages 1-2 pages 2-4 Deu.se... sets 4-8 nic arid and its SUMMA: AND CXPLANATION INH test sirigs were vevcloped by Riloum vt al. to moniter patiests on isoniaziu inerany on an outpahent basis Tne test aids n.si.iarts in determinn_ . heuer their patients are ‘acing tne prescrized ...edication. The reagerit wpregnated paver stric detects the presence of isonico'inic acid in te patients urine. .nc strip me*hod is a modification o. Kilburn an Kubica s strip p ocedure..o, uetecting niac.n produ.ed by M wherculsis.2 PRINCI#LES Cr THE PROCEUU~E ‘The nyridine ring o- isonicotinic acid is split by cyanozen c_loride to forma Tlutaconaldeh’ de derivative. This deri-ative condenses with barbituri. acid to form a blue-purple polymethine de REAGENTS BD BBL Taxo INH Test sirips are absorbent paper strips impregnated with chloramine T, potassium thiocyanate, citric acid and barbituric acid as described by Kilburn et al. with some modifications. BD BBL Taxo INH Test Control is an INH impregnated disc that will yield a positive result in the test procedure. waning» atid Precautions: For in vitro Diagnostic Use. Storage inst:uctions: Store BD BBL Taxo INH Test Strips at 2 — 4 °C. Store BD BBL Taxo INH Test Control at #5 - 30°C. After opening, store both products at the indicated temperature in the dark. The expiration date applies to the product in its intact container when stored as directed Product Deterioration: Do not use a product if it fails to meet specifications for identity and performance. SPECIMEN COLLE ‘TION AND HANDLING Collect freshly voided urine 10 — 12 h after drug isoniazid administration. PRO EDURE Materials Provide.: GD B3L laxo INH Test _trips and/or Bu BBL Taxo INH Test Control Materi7is Req 1 red But Not Provided: Test tubes, in wit itu dixgs0 tie > ur! Daspustit medion vied gual invvu, Median na po~age" 8 wit” Uagnustik. in vue vagnascbke orvesi eszkaz / Dispositivo medica. ..r diagnostic in vitro /mavat. A.OSW08 * Wtie TH M pt gman gita-Hon#Ka —cnaGss In vitro diagnostikos pritaisas ! M.dicinas ieric_s. ko lato in vitro disgnostié / MLdisch -w.nnidde: veor in vitro diagnastek / In vitro diagnostisx medisinsk atstyr / Urzdzenie m.d,czne do diagnost; \i in vitra / Dispositive médico para diegn-stieo in Vito | Disporitiy medica ‘pentru diagnostic in vitro | Viemmupie wit pop ane aitereocTinan in vitro ! M.dicinsks pamécka na diagnostinu in vitro / Medicinski ured za in vitro oijagnesti | Medicinteknisk produkt f-r in vitro-diagnostik / in Vitro Diyagnostik Tibbi Cihaz / Meamunvit npwespilé ANA giarwocriaat in vitro ‘Tempersture linvtstion | Tewnepstypka orpasituenan / Teplotn! omezent / { Temperaturbegncnsning / Temperaturbegrenzung / T.cproprcyo! epyonpaciag / Limitacién de temperatura | Temperstuuri pirang / Limites de tempcrature / Dazvollens tempersturs ! Héeeérsékieti hatér / Limit di temperstura / Teuneperyperitl wesrey / Leikt-mo temperstiira / Temperaiiras ierobedojumi / Temperatuurlimist | fe,n,erat-rbegrensning J Igranic.enie temperatu.y I Limi es. sempersturs / Limite de temperatura ! O paawuenne Teunepstypel / Uhranizenie teploty /_granidenje temperature / Tempersturgrans / Sieaklk sinilamesi / O iekeHHn TemnepstypH Baten Go-e {Lat} / Kr Ha napraaara / Kéd (@ slo) Earke / Bac -kode (ot) ’ Gatch Coae LOT, (Cha.gey/ um, naptiéa, (apt. 1! / Cédige de lote (lote) /; 9.41 :00d / humd.od ot! ot (kod) / Ttel s2*ms Lot) / Codice estch lotto} / To-.isma kone. / Pariijos .umeris (0 }/ Parties Kos (1 idie 8) Lot numer Bt ickode (arti Kad sant (sna, / Gédiyo do ete / Cadde erie (Lot) / Ko. ..aprim (ror) /Kéd érie (Lerda)/ hod serie / Partinummer (Lot) /r arti Kodu (Lot) / Ko napri mnodsivi pra tesit/ Indaholder ilstreg.xeligt tl tesis / Ausreichend fir- Tesis / Twin sap. Tecéryra ya “h> ~Eevo-1g / Contenido suficiente pera pruebas JK lisidane n> festide jaoks /Co.t wu flsact pour s.r t, st « Sadria) za +> testov /- pirbsud_m// Inhaud valdosnde voor *n”testen / Innholder flstekcelig ti tester / Zewiera llndé wystarcesjeca do testéw / Gontetico suficiente pare -sn> testes / CConfinut suicient pentru teste / Jocterowo ana tecroa(a} / Obsah vysiadi ne testov 1 SedrEs dovolian zs testova / Innehille tilrackigt for test ign ,eterl makeme i ent! etaur ana suanisie: <> yy Contains suffcient for

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