Poly stat HCG-POCU

• FDA 510(k) K921206 decided 29 Apr 1992 Active
• FDA GUDID UDI-DI 00855574005391 listed 23 Sep 2016 Listed

1. 29 Apr 1992 Cleared FDA 510(k) K921206
2. 23 Sep 2016 Listed FDA GUDID 00855574005391

Trade name

Poly stat

Generic name

Human chorionic gonadotropin alpha-subunit IVD, control

Model / reference

HCG-POCU

Primary DI / UDI-DI

00855574005391

510(k) Number

K921206 ↗

FDA product code

JJX

GMDN term

Human chorionic gonadotropin alpha-subunit IVD, control

Device class

Class I

Regulation number

862.1660

GUDID distribution status

In Commercial Distribution

Category: Human chorionic gonadotropin alpha-subunit IVD, control

Other devices filed under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)).

• LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK by Bio-Rad Laboratories
• POSITIVE AND NEGATIVE HCG SERUM CONTROLS by Armkel, LLC
• IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA by Siemens Healthcare Diagnostics
• IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL by Siemens Healthcare Diagnostics
• DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT by General Atomics
• OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION by Bionostics, Inc.
• CLINIQA LIQUID QC TDM CONTROLS LEVELS 1, 2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM by Cliniqa Corporation
• LTA Check Test Kit 107117 by Bio/Data Corporation
• ELECSYS CALCHECK FERRITIN by Roche Diagnostics GmbH
• Diazyme DZ168C-CON by Diazyme Laboratories, Inc.

• 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. →