Kit, Test, Pregnancy, Hcg, Over The Counter
FDA product code LCX · 224 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
- 1978-01-05 – 2025-09-09
LCX
2001-08-14
LCX
2001-08-07
QUIK-CHECK HOME PREGNANCY TEST
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LCX
2000-07-27
INVERNESS MEDICAL EARLY PREGNANCY TEST
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LCX
2000-01-20
ACON ONE STEP HOME PREGNANCY TEST STRIP
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LCX
1999-12-21
FIRST RESPONSE 1-STEP PREGNANCY
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LCX
1999-12-16
CLEARPLAN EASY II HOME PREGNANCY TEST
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LCX
1999-11-08
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
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LCX
1999-05-10
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
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LCX
1999-05-04
SAS HCG-CHECK
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LCX
1999-04-07
CLEARPLAN EASY HOME PREGNANCY TEST
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LCX
1999-03-09
OSOM CARD PREGNANCY TEST, MODEL 103
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LCX
1999-02-22
FACT PLUS ONE STEP PREGNANCY TEST
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LCX
1999-02-16
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
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LCX
1998-11-18
ACON MIDSTREAM PREGNANCY TEST
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LCX
1998-08-18
QUICK & SURE ONESTEP HOME PREGNANCY TEST
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LCX
1998-06-03
QUIDEL HOME PREGNANCY TEST
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LCX
1998-04-09
ONE STEP MIDSTREAM HCG PREGNANCY TEST
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LCX
1998-03-11
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
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LCX
1998-01-26
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
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LCX
1997-12-19
CHOICE ACCU-TEST PREGNANCY TEST KIT
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LCX
1997-12-19
SIGNAL PREGNANCY TEST KIT
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LCX
1997-10-31
QUICK CARD HCG ONE STEP PREGNANCY TEST
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LCX
1997-10-27
BRAND NAME *1-STEP PREGNANCY
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LCX
1997-10-20
FIRST SIGN
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LCX
1997-08-01
QUICKSTICK ONE STEP HCG PREGNANCY TEST
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LCX
1997-05-08
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
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LCX
1997-03-06
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
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LCX
1997-02-18
ADVANCED QUALITY PREGNANCY TEST
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LCX
1997-02-04
PERFECTA PREGNANCY TEST
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LCX
1997-01-24
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
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LCX
1996-12-02
MIDSTREAM ONESTEP PREGNANCY HOME TEST
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LCX
1996-11-18
FACT PLUS PREGNANCY TEST
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LCX
1996-11-07
NATURALE HCG PREGNANCY TES
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LCX
1996-10-01
EVIDENCE PREGNANCY TEST
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LCX
1996-09-23
AFFIRM ONE-STEP HOME PREGNANCY TEST
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LCX
1996-08-29
EZ SURE ONESTEP EARLY PREGNANCY TEST
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LCX
1996-07-29
FACTPLUS ONE STEP PREGNANCY TEST
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LCX
1996-07-23
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
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LCX
1996-07-10
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
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LCX
1996-06-24
SURE CHECK PREGNANCY TEST
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LCX
1996-05-31
TBD AT-HOME PREGNANCY TEST
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LCX
1996-05-01
MINISTICK PREGNANCY TEST
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LCX
1996-04-29
CLEARBLUE EASY
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LCX
1996-04-01
UNIMARK MIDSTREAM PREGNANCY TEST STICK
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LCX
1996-03-22
BEST PREGNANCY TEST
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LCX
1996-03-19
SELFCARE EARLY PREGNANCY TEST
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LCX
1996-03-19
PLATFORM ONESTEP PREGNANCY HOME TEST
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LCX
1996-03-06
SELFCARE EARLY PREGNANCY TEST
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LCX
1995-10-23
OSOM PREGNANCY TEST
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LCX
1995-10-13
CAMEO HOME PREGNANCY TEST
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LCX
1995-07-19
HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY
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LCX
1995-02-10
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
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LCX
1995-01-27
ADVANCE(R) PREGNANCY TEST
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LCX
1995-01-17
HCG MIDSTREAM PREGNANCY TEST
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LCX
1994-10-20
HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE
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LCX
1994-07-06
BODYWISE PREGNANCEY TEST
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LCX
1994-07-06
PREGNANCY CHECK
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LCX
1994-06-02
PREDICTOR HOME PREGNANCY TEST
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LCX
1994-05-19
ANI BIOCARD(TM) HCG TEST
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LCX
1994-02-25
EVATEST STRIP
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LCX
1994-02-24
ADVANCE PREGNANCY TEST MODIFICATION
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LCX
1993-12-02
HCG PREGNANCY ONE STEP TEST STRIP
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LCX
1993-09-10
HCG MIDSTREAM PREGNANCY TEST
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LCX
1993-04-06
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
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LCX
1993-03-18
PRECISE PREGNANCY
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LCX
1993-01-26
LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST
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LCX
1993-01-06
PREGNAGEN 1-STEP PREGNANCY TEST
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LCX
1992-12-28
CONCEIVE ONE-STEP PREGNANCY TEST
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LCX
1992-05-29
SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
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LCX
1992-04-08
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
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LCX
1991-12-23
ADVANCE(R) PREGNANCY TEST
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LCX
1991-10-17
FIRST RESPONSE(R) ONE-STEP
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LCX
1991-10-17
HOMECLINIC ONE STEP PREGNANCY TEST
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LCX
1991-07-24
QUIKPAC-II ONE STEP PREGNANCY HOME TEST
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LCX
1991-05-06
CLEARBLUE EASY
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LCX
1991-02-13
CLEARBLUE EASY
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LCX
1990-12-06
ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST
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LCX
1990-08-02
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
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LCX
1990-03-06
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
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LCX
1989-11-13
MODIFIED HOMECLINIC PREGNANCY TEST
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LCX
1989-03-08
C&T PREGNANCY TEST KIT
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LCX
1989-01-30
PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
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LCX
1988-11-29
HOME CLINIC PREGNANCY TEST
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LCX
1988-10-25
DISCOVER(R)
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LCX
1988-10-06
BLUE DOT(TM) TEST FOR PREGNANCY
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LCX
1988-07-28
CLEARBLUE EASY
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LCX
1988-05-16
ADVANCE* AND DAISY* PREGNANCY TEST
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LCX
1988-04-05
FIRST RESPONSE 5 MINUTE PREGNANCY TEST
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LCX
1988-02-11
LEECO PREGNASTICK (EIA) CATALOG #003
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LCX
1987-11-04
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
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LCX
1987-08-26
ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST
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LCX
1987-08-18
ABBOTT BIOTELL PREGNANCY TEST
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LCX
1987-01-14
CARDS(TM) - EARLY PREGNANCY TEST
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LCX
1987-01-09
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
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LCX
1987-01-09
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
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LCX
1986-12-22
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
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LCX
1986-06-17
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
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LCX
1986-06-16
PTK PLUS. HOME PREGNANCY TEST
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LCX
1986-04-24
CLEARBLUE PREGNANCY TESTING KIT
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LCX
1986-04-21
MUREX (TM), SUDS (TM), HCG ASSAY
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