Product code JHI— Clinical Chemistry
BIONIKE A/Q PREGNANCY TEST
- Classification name
- Visual, Pregnancy Hcg, Prescription Use
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Total cleared
- 376
- First cleared
- Most recent
Clearances under product code JHI — page 3
201–300 of 376- K894175 — SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
- K895809 — MILENIA(TM) HCG (MKCG1,5)
- K895912 — IMMUNOCARD HCG II-S TEST KIT
- K895390 — CARDS O.S. (TM) HCG-URINE
- K894790 — QUIDEL HCG TEST
- K894941 — COAT-A-COUNT (TM) HCG IRMA
- K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST
- K894750 — BIOSTIX I. HCG - ONE STEP PREGNANCY TEST
- K894420 — ORTHO RESULT PLUS/PREGNANCY
- K894182 — IMX TOTAL B-HCG
- K894408 — ABBOTT TESTPACK PLUS HCG URINE
- K894012 — MINICLINIC PREGNANCY TEST
- K891770 — HCG IRMA II
- K890615 — DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
- K890549 — VENTREX COATED TUBE HCG
- K890131 — TARGET(TM) QUANTITATIVE HCG
- K884616 — FIRSTDAY EARLY PREGNANCY TESTING KIT II
- K884880 — PREGNAGEN(TM)
- K883927 — CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
- K883639 — MODIFIED HCG IRMA KIT
- K883777 — CLEARVIEW HCG
- K882002 — PREGNAGEN(TM)
- K881015 — FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
- K882155 — COTUBE HCG IRMA TEST
- K881806 — QLT ABSOLUTE URINE-HCG PREGNANCY TEST
- K882086 — QTEST(TM) PREGNANCY
- K881709 — IMMUNOCARD(TM) HCG II TEST KIT
- K881355 — AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT
- K881005 — IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG
- K881595 — QUIDEL PREGNANCY TEST
- K880410 — HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT
- K880070 — ABBOTT IMX HCG
- K880577 — CONCEP-7-BHCG
- K874388 — KODAK SURECELL(TM) HCG-URINE KIT
- K874033 — IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
- K873788 — CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504
- K874258 — VENTRESCREEN, HCG URINE
- K872730 — RESULT PLUS/HCG PREGNANCY TEST
- K873524 — AFFINITY HCG IMMUNIT (POLYCLONAL)
- K873033 — HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE
- K872390 — ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
- K872728 — BINAX IRMA TOTAL BETA-HCG TEST KIT
- K872130 — ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
- K871700 — HCG MAB SOLID PHASE COMPONENT SYSTEM
- K871308 — ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT
- K871235 — TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
- K870627 — AFFINITY (TM) HCG IMMUNIT (TM)
- K870739 — ABBOTT TESTPACK HCG COMBO
- K870751 — SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST
- K870521 — TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
- K870672 — ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
- K864174 — UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE
- K870106 — COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
- K865057 — TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
- K870259 — VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
- K865076 — SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST
- K864591 — HCG SOLID PHASE COMPONENT SYSTEM
- K863933 — VIS-CUBE HCG (EIA)
- K863861 — TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
- K863032 — ABBOTT TESTPACK (TM) HCG SERUM
- K863199 — CARDS(TM) HCG-URINE
- K862247 — TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
- K862262 — HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
- K862007 — HCG IRMA, CAT. NO. CR-1501
- K860965 — BETA QUIK STICK
- K860490 — MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY
- K860542 — TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
- K854958 — HCG RIA TEST SYSTEM
- K854059 — MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
- K854989 — CANWEST-PREGBLUE
- K854611 — RAMP URINE HCG ASSAY
- K852760 — LBK 1244 DELFIA HCG KIT
- K854104 — IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)
- K853925 — QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
- K854024 — CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
- K853258 — BETA-HCG MICROTITER PREGNANCY TEST
- K853748 — VENTRESCREEN HCG URINE
- K853539 — ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
- K853006 — HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY
- K852327 — BETA QUIK STAT
- K852675 — AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT
- K852437 — VISUAL SERUM/URINE HCG COMBO KIT
- K852183 — BETA HCG EXTENDED RANGE ACCESSORY KIT
- K852201 — ECHOCLONAL HCG IRMA
- K850727 — BHCG-ROCHE EIA
- K851076 — UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST
- K850992 — PREGNA-ZYME
- K850949 — MEDIX VISUAL URINE HCG (7/7) TEST
- K850987 — MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM
- K850530 — LEECO CONCEP-7-BHCG IRMA
- K850531 — LEECO CONCEP-7-BHCG EIA
- K850570 — STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
- K850730 — MODEL SERUM HCG ASSAY
- K850159 — TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
- K850201 — LEECO CONCEP-7-BHCG LEIAD II
- K844153 — CONCEP-7-BHCG (EIA)
- K844082 — QUEST BETA HCG ENZYME IMMUNOASSAY KIT
- K843795 — BETA QUIK V
- K843407 — ENCORE HCG REAGENT
- K842654 — EPSILON HCG TEST KIT MONOCLONAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.