Product Code: JHI


Products Classified as JHI

416Visual, Pregnancy Hcg, Prescription UseHuman Chorionic Gonadotropin (HCG) Test System.

Total Product Life Cycle (TPLC) Devices

416Visual, Pregnancy Hcg, Prescription UseHuman Chorionic Gonadotropin (HCG) Test System.

Pre-market Notifications for JHI

K172322Atellica IM Total HCG (ThCG)Siemens Healthcare Diagnostics Inc.
K172257TrueDX 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)True Diagnostics, Inc
K152768Assure Tech HCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech HCG Pregnancy Serum/Urine Combo Test StripASSURE TECH. CO., LTD.
K132834FASTEP S10 HCG SERUM/URINE COMBO TESTPOLYMED THERAPEUTICS, INC
K131166SOFIA(R) HCG FIAQUIDEL CORP.
K130456WUNDER PREGNANCY TESTJAMES NGUYEN
K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TESTCHEMTRON BIOTECH, INC.
K112315HOME PREGNANCY TESTNEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
K112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSPOLYMED THERAPEUTICS, INC
K102175RAPIDVUE HCG TESTQUIDEL CORPORATION
K072264FASTPACK HCG IMMUNOASSAYQualigen, Inc.
K071030BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGCAPPLIED DNA TECHNOLOGIES, INC.
K070921BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCGAPPLIED DNA TECHNOLOGIES, INC.
K062361INNOVACON HCG UKTRA TEST DEVICEINNOVACON, INC.
K061257DBEST HCG PANEL TEST KITAMERITEK USA, INC.

Global Unique Device Identification Database

00613647000588Visual, pregnancy hCG, prescription use
00613647000571Visual, pregnancy hCG, prescription use
00613647000564Visual, pregnancy hCG, prescription use
00613647000540Visual, pregnancy hCG, prescription use
00613647000533Visual, pregnancy hCG, prescription use
00613647000526Visual, pregnancy hCG, prescription use
00630414600079Visual, pregnancy hCG, prescription use
00630414600062Visual, pregnancy hCG, prescription use
00630414600055Visual, pregnancy hCG, prescription use
00630414600048Visual, pregnancy hCG, prescription use
00630414600031Visual, pregnancy hCG, prescription use
00630414600024Visual, pregnancy hCG, prescription use
00630414505183Visual, pregnancy hCG, prescription use
00630414505176Visual, pregnancy hCG, prescription use
00630414505152Visual, pregnancy hCG, prescription use

Maude Adverse Events

ALERE HCG CASSETTE (20 MIU/ML)ALERE SAN DIEGO, INC.2020-03-26
CLINITEK STATUS+ UKSIEMENS HEALTHCARE DIAGNOSTICS2020-03-25
HENRY SCHEIN HCG URINE CASSETTE 100TALERE SAN DIEGO2020-03-24
MEDLINE HCG COMBO CASSETTEALERE SAN DIEGO, INC.2020-03-17
FISHER - SURE-VUE HCG URINE CASS. (30T)ALERE SAN DIEGO2020-03-12
FISHER - SURE-VUE HCG URINE CASS. (30T)ALERE SAN DIEGO2020-03-12
MEDLINE HCG URINE DIPSTICKALERE SAN DIEGO2020-03-12
HCG ONE STEP PREGNANCY TEST STRIP (URINE)ALERE SAN DIEGO2020-03-12
ADVIA CENTAUR CP TOTAL HCG ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-03-12
MEDLINE HCG URINE CASSETTEALERE SAN DIEGO2020-03-11
CLINITEK STATUS+SIEMENS HEALTHCARE DIAGNOSTICS2020-02-28
CONSULT HCG URINE CASSETTE 5001 25TALERE SAN DIEGO2020-02-19
ADVIA CENTAUR XPT TOTAL HCG (THCG)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-13
ADVIA CENTAUR XPT TOTAL HCG (THCG)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-13
CONSULT HCG URIN/SRM COMBO 5002 25ALERE SAN DIEGO, INC.2020-02-13
HCG ONE STEP PREGNANCY TEST STRIP (URINE)ALERE SAN DIEGO2020-02-12
CLINITEK STATUS+SIEMENS HEALTHCARE DIAGNOSTICS2020-02-10
CONSULT HCG URINE CASSETTE 5001 25TALERE SAN DIEGO2020-02-07
CONSULT HCG URINE CASSETTE 5001 25TALERE SAN DIEGO2020-02-07
FISHER-SURE-VUE HCG STAT SRM/URINEALERE SAN DIEGO, INC.2020-01-14
CONSULT HCG URINE CASSETTE 5001 25TALERE SAN DIEGO, INC.2020-01-07
CARDINAL HEALTH RAPID TEST HCG COMBO 30TALERE SAN DIEGO, INC.2020-01-07
FISHER-SURE-VUE HCG-STAT SRM/URINE (30T)ALERE SAN DIEGO, INC.2020-01-07
ATELLICA IM TOTAL HCG (THCG)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-01-06
FISHER-SURE-VUE HCG-STAT SRM/URINE (30T)ALERE SAN DIEGO, INC.2019-12-20
CONSULT HCG URINE CASSETTE 5001 25TALERE SAN DIEGO2019-12-03
ALERE HCG COMBO CASSETTE (20/10MIU/ML)ALERE SAN DIEGO, INC.2019-11-27
ALERE HCG COMBO CASSETTE (20/10MIU/ML)ALERE SAN DIEGO, INC.2019-11-27
ALERE HCG COMBO CASSETTE (20/10MIU/ML)ALERE SAN DIEGO, INC.2019-11-27
HCG ONE STEP PREGNANCY TEST STRIP (URINE)ALERE SAN DIEGO2019-11-25
SURESTEP HCG URINE CASSETTEALERE SAN DIEGO, INC.2019-11-22
MEDLINE HCG URINE CASSETTEALERE SAN DIEGO, INC.2019-11-22
ALERE HCG CASSETTEALERE SAN DIEGO, INC.2019-11-22
CARDINAL HEALTH RAPID TEST HCG CASSETTEALERE SAN DIEGO, INC.2019-11-19
CARDINAL HEALTH RAPID TEST HCG CASSETTEALERE SAN DIEGO, INC.2019-11-18
CARDINAL HEALTH RAPID TEST HCG CASSETTEALERE SAN DIEGO, INC.2019-11-18
HCG ONE STEP PREGNANCY TEST DEVICE (URINE)ALERE SAN DIEGO2019-11-13
MEDLINE HCG URINE CASSETTEALERE SAN DIEGO2019-11-12
MEDLINE HCG URINE DIPSTICKALERE SAN DIEGO2019-11-11
CARDINAL HEALTH RAPID TEST HCG CASSETTEALERE SAN DIEGO2019-11-04
CARDINAL HEALTH RAPID TEST HCG CASSETTEALERE SAN DIEGO2019-11-04
CARDINAL HEALTH RAPID TEST HCG CASS. 30TALERE SAN DIEGO, INC.2019-11-04
CARDINAL HEALTH RAPID TEST HCG CASSETTEALERE SAN DIEGO2019-11-01
CARDINAL HEALTH RAPID TEST HCG CASS. 30TALERE SAN DIEGO, INC.2019-11-01
FISHER-SURE-VUE HCG-STAT SRM/URINEALERE SAN DIEGO2019-10-24
MEDLINE HCG COMBO CASSETTEALERE SAN DIEGO, INC2019-10-23
MEDLINE HCG COMBO CASSETTEALERE SAN DIEGO, INC2019-10-23
MEDLINE HCG COMBO CASSETTEALERE SAN DIEGO, INC2019-10-23
MEDLINE HCG COMBO CASSETTEALERE SAN DIEGO, INC2019-10-23
MEDLINE HCG COMBO CASSETTEALERE SAN DIEGO, INC2019-10-23

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