Poly stat HCG25

• FDA 510(k) K020439 decided 23 May 2002 Active
• FDA GUDID UDI-DI 00855574005384 listed 23 Sep 2016 Listed

1. 23 May 2002 Cleared FDA 510(k) K020439
2. 23 Sep 2016 Listed FDA GUDID 00855574005384

Trade name

Poly stat

Generic name

Human chorionic gonadotropin alpha-subunit IVD, kit, rapid ICT, clinical

Model / reference

HCG25

Primary DI / UDI-DI

00855574005384

510(k) Number

K020439 ↗

FDA product code

JHI

GMDN term

Human chorionic gonadotropin alpha-subunit IVD, kit, rapid ICT, clinical

Device class

Class II

Regulation number

862.1155

GUDID distribution status

In Commercial Distribution

Category: Human chorionic gonadotropin alpha-subunit IVD, kit, rapid ICT, clinical

Other devices filed under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use).

• MILENIA(TM) HCG (MKCG1, 5) by Diagnostic Products Corp.
• EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST by Excel Scientific, Inc.
• CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO by Quidel Corp.
• MAINLINE MAXIE HCG URINE PREGNANCY TEST by Mainline Technology, Inc.
• ORTHO RESULT PLUS/PREGNANCY by Ortho Diagnostic Systems, Inc.
• CONTRAST & RAPID HCG URINE/SERUM TST by Medix Biotech, Inc.
• QuickVue+ hCG S/U Test 00178 by Quidel Corp.
• QUIKPAC II, ONE STEP HCG COMBO KIT by SYNTRON BIORESEARCH, INC.
• DSL ACTIVE I-HCG IRMA by Diagnostic Systems Laboratories, Inc.
• NOW PREGNANCY TEST KIT by Bio Clinic Co.

• C-Reactive Protein (Crp) Agglutination Latex Kit

  Class II

  FDA 510(k) K962049 Active Cleared 18 Dec 1996

• Poly stat STS25

  Class I

  FDA 510(k) K040708 Active Cleared 22 Nov 2004 GUDID on market

• Poly stat HCG-POC

  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

• Poly stat FLU25

  Class I

  FDA 510(k) K132465 Active Cleared 9 Sep 2013 GUDID on market

See all devices from Polymedco, Inc. →