Panels › Clinical Chemistry › Product code JHI · Class 2
Visual, Pregnancy Hcg, Prescription Use
Regulation 862.1155
1510(k)s in 12 months (376 all time)
4recalls in 12 months (47 all time)
34recalls that name a 510(k)
Top companies in JHI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526;
Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073;
Alere hCG Cassette (25mIU/mL) in Open, Classified |
JHI | K993317 |
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527;
McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000;
Henry Schein One Step+ hCG Urine Strip Test, Open, Classified |
JHI | K993203 |
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528;
Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;
Henry Schein One Step+ hCG Combo test in S Open, Classified |
JHI | K993065 |
| Sep 25, 2026 | Alere San Diego, Inc. McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;
Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210;
Fisher Scientific Sure-Vue Serum/UrinehCG-STAT, Model/ Part: FHC- Open, Classified |
JHI | K062361 |
| Oct 30, 2024 | Princeton Biomeditech Corp Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy.
Model/Catalog Number: 1004 Open, Classified |
JHI | K944426 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 Open, Classified |
JHI | K963133 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 Open, Classified |
JHI | K050741 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 Open, Classified |
JHI | K963132 |
| Oct 23, 2023 | Universal Meditech Inc. Lem Fertility hCG Pregnancy Urine Test REF 100-12 Open, Classified |
JHI | K963132 |
| Oct 23, 2023 | Universal Meditech Inc. To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 Open, Classified |
JHI | K963132 |
| Oct 23, 2023 | Universal Meditech Inc. DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 Open, Classified |
JHI | K050741 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210.
b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Open, Classified |
JHI | K062361 K993203 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002.
b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test Open, Classified |
JHI | K062361 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK HCG; Part Number: 025261
Assay, Reproductive Hormone Terminated |
JHI | K870521 |
| Oct 20, 2016 | Ekla Corporation NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS
Product Usage:
pregnancy test Terminated |
JHI | K112101 |
| May 25, 2013 | Alere San Diego, Inc. Alere" hCG Combo Cassette (20/10 mIU/mL) Kit.
Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonado Terminated |
JHI | K062361 |
| May 21, 2013 | Alere San Diego, Inc. Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026)
The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorio Terminated |
JHI | K993317 |
| Feb 7, 2012 | Siemens Healthcare Diagnostics Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105).
For in vitro diagnostic u Terminated |
JHI | K032563 |
| Oct 17, 2011 | Beckman Coulter Inc. Access Immunoassay Systems Total hCG.
The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and pla Terminated |
JHI | K023480 |
| Mar 21, 2011 | Beckman Coulter Inc. Access Total BhCG (BhCG) Assay Part Number 33500
The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human s Terminated |
JHI | K980173 |
| Mar 1, 2011 | Quidel Corporation QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842 Terminated |
JHI | K020799 |
| Jan 15, 2009 | Mainline Technology, Inc. Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C. Terminated |
JHI | None listed |
| Jan 15, 2009 | Mainline Technology, Inc. f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065. Terminated |
JHI | None listed |
| Jan 15, 2009 | Mainline Technology, Inc. Mainline Confirms hCG Serum/Urine III, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-25. Terminated |
JHI | None listed |
| Jan 15, 2009 | Mainline Technology, Inc. Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001. Terminated |
JHI | None listed |
| Jan 15, 2009 | Mainline Technology, Inc. Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-CTR. Terminated |
JHI | None listed |
| Jan 15, 2009 | Mainline Technology, Inc. Mainline Confirms Strep A DOTS, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 4040. Terminated |
JHI | None listed |
| Jan 15, 2009 | Mainline Technology, Inc. Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40. Terminated |
JHI | None listed |
| Sep 1, 2008 | Siemens Medical Solutions Diagnostics In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro d Terminated |
JHI | K032563 |
| Sep 1, 2008 | Siemens Medical Solutions Diagnostics Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system
Product Number: 1760 Terminated |
JHI | None listed |
| May 6, 2008 | Innovacon Inc Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Di Terminated |
JHI | K062361 |
| Nov 21, 2007 | Applied Biotech Inc Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directiona Terminated |
JHI | None listed |
| Nov 21, 2007 | Applied Biotech Inc Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medica Terminated |
JHI | None listed |
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing animal serum. Terminated |
JHI | K935673 |
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bo Terminated |
JHI | K935673 |
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B- hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF Terminated |
JHI | K935673 |
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7 Terminated |
JHI | K935673 |
| Jun 9, 2006 | Applied Biotech Inc Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007 Terminated |
JHI | None listed |
| Aug 24, 2005 | Abbott Laboratories MPG ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Ab Terminated |
JHI | K903219 |
| Aug 24, 2005 | Abbott Laboratories MPG ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Labora Terminated |
JHI | K965116 |
| Jun 16, 2005 | Abbott Health Products, Inc. IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluen Terminated |
JHI | K912535 |
| Jun 16, 2005 | Abbott Health Products, Inc. AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. Terminated |
JHI | K935673 |
| Oct 5, 2004 | Abbott Health Products, Inc. AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 Terminated |
JHI | K935673 |
| Sep 2, 2004 | Abbott Health Products, Inc. AxSYM Total B-hCG Reagent Pack Terminated |
JHI | K935673 |
| Jul 20, 2004 | Beckman Coulter Inc ICON 25 hCG Test Kit Terminated |
JHI | None listed |
| Jan 29, 2004 | Beckman Coulter Inc ICON 25 hCG test kit. Terminated |
JHI | None listed |
| Apr 2, 2003 | Beckman Coulter Inc ICON DS hCG, an in-vitro diagnostic. Part number 44025. Terminated |
JHI | K993203 |
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