Visual, Pregnancy Hcg, Prescription Use
FDA product code JHI · 374 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1155
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-12 – 2026-09-22
JHI
2026-09-22
JHI
2024-08-02
Innovita HCG Pregnancy Rapid Combo Test
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JHI
2022-01-31
Alltest Pregnancy Rapid Combo Test Cassette
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JHI
2018-03-29
Atellica IM Total hCG (ThCG)
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JHI
2017-12-22
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
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JHI
2016-02-24
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
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JHI
2013-08-02
SOFIA(R) HCG FIA
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JHI
2013-05-30
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
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JHI
2012-07-17
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
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JHI
2012-04-23
HOME PREGNANCY TEST
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JHI
2010-08-25
RAPIDVUE HCG TEST
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JHI
2007-12-06
FASTPACK HCG IMMUNOASSAY
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JHI
2007-06-29
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
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JHI
2007-06-29
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
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JHI
2007-05-04
DBEST HCG PANEL TEST KIT
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JHI
2006-10-23
INNOVACON HCG UKTRA TEST DEVICE
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JHI
2006-01-23
LIFESIGN DXPRESS, MODEL LSR2000
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JHI
2005-12-16
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
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JHI
2005-08-22
WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
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JHI
2005-05-16
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
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JHI
2005-04-12
OSOM HCG COMBO TEST
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JHI
2004-08-16
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
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JHI
2004-08-11
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
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JHI
2004-03-18
ZAP HCG TEST, MODEL 8001
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JHI
2003-12-23
CLINITEST HCG PREGNANCY TEST
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JHI
2003-11-17
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
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JHI
2003-07-01
MAINLINE MAXIE HCG URINE PREGNANCY TEST
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JHI
2003-06-16
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
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JHI
2003-05-22
EASYCUP
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JHI
2003-04-18
POLY STAT SERUM/URINE HCG TEST
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JHI
2003-02-11
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
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JHI
2003-01-16
GENZYME CONTRAST II HCG URINE/SERUM TEST
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JHI
2002-12-20
ACCESS TOTAL BHCG
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JHI
2002-12-16
SAS BLOOD/SERUM/URINE/URINE HCG
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JHI
2002-08-05
POLY STAT HCG DIPSTICK TEST
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JHI
2002-07-15
LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
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JHI
2002-06-21
QUPID PLUS E.R.
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JHI
2002-05-23
STATUS HCG SERUM/URINE
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JHI
2002-05-17
QUICKVUE ONE-STEP HCG-COMBO
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JHI
2002-05-17
QUICKVUE ONE-STEP HCG-URINE
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JHI
2002-03-08
SAS VALUE HCG
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JHI
2002-03-01
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
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JHI
2001-12-27
VICTORCH HCG TEST STRIP
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JHI
2001-10-16
POLY STAT HCG TEST
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JHI
2001-10-10
UNIMARK HCG COMBO PREGNANCY TEST
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JHI
2001-08-28
WH ACCU TEST PREGNANCY TEST
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JHI
2001-08-14
HCG STAT PAK ULTRA-FAST
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JHI
2001-07-31
SUREVUE URINE HCG
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JHI
2001-04-05
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
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JHI
2001-02-21
EZ-HCG URINE(PREGNANCY TEST)
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JHI
2000-06-22
DBEST HCG 2 IU/ML TEST KIT
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JHI
2000-02-03
ADVANTAGE HCG TEST (URINE/SERUM)
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JHI
1999-12-02
CLEARVIEW EASY HCG PREGNANCY TEST
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JHI
1999-12-01
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
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JHI
1999-12-01
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
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JHI
1999-11-18
ONE-STEP DOUBLE-CHEK PREGNANCY TEST
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JHI
1999-10-18
INSURE PRO TEST
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JHI
1999-10-08
ACON COMBO PREGNANCY
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JHI
1999-08-26
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
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JHI
1999-07-22
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
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JHI
1999-05-10
SAS ONE-STEP PREGNANCY
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JHI
1999-05-10
MODIFICATION OF SAS SERUM/URINE HCG
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JHI
1999-04-28
QUICKCARD HCG COMBO TEST, MODEL #9014
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JHI
1999-04-27
MODIFICATION OF: DAVIDSTRIP HCG
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JHI
1999-03-09
OSOM CARD II HCG-URINE TEST, MODEL 102
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JHI
1999-02-16
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
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JHI
1999-02-16
INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
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JHI
1999-02-16
INSTANT-VIEW PREGNANCY COMBO TEST
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JHI
1999-02-16
INSTANT-VIEW PREGNANCY URINE TEST
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JHI
1998-07-22
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
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JHI
1998-06-25
ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
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JHI
1998-06-25
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
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JHI
1998-06-05
RAPIDHCG PREGNANCY TEST
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JHI
1998-05-28
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
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JHI
1998-04-16
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
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JHI
1998-04-16
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
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JHI
1998-04-09
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
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JHI
1998-04-02
QUICKCARD PRO HCG TEST, MODEL 9008
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JHI
1998-03-18
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
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JHI
1998-03-13
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
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JHI
1998-03-06
AIMSTEP PREGNANCY
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JHI
1998-02-12
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
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JHI
1998-01-26
QUICKSTICK PRO HCG TEST
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JHI
1998-01-22
SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
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JHI
1997-12-24
OSOM HCG-URINE TEST MODEL 101
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JHI
1997-12-19
QUICKVUE SEMI-Q HCG-COMBO
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JHI
1997-12-17
DBEST ONE-STEP HCG SERUM/URINE TEST
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JHI
1997-12-01
QUICKVUE ONE-STEP HCG-COMBO
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JHI
1997-11-26
CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO
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JHI
1997-11-04
OSOM CARD HCG-URINE TEST
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JHI
1997-08-29
CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE
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JHI
1997-08-29
QUICKVUE ONE-STEP HCG-URINE
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JHI
1997-06-11
ACCUTEST HCG-URINE
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JHI
1997-04-25
ACCULINE PREGNANCY TEST
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JHI
1997-04-04
CLINITEK HCG TEST STRIPS
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JHI
1997-03-06
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
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JHI
1997-02-20
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
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JHI
1997-02-20
ACCUPACK PREGNANCY TEST
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JHI
1997-02-18
SAS PREGNANCY STRIP
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JHI
1997-02-18
SAS SERUM/URINE HCG
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