Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005146313

FEI Number

3005146313

Entity Name

SANZAY CORPORATION -

City/State/Country

Miami Gardens, FL, US

Establishment Address

1080 NW 163rd Drive, Miami Gardens, FL 33169, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Sanzay Corporation - Integrated Diagnostics Group (Owner Number: 10026301)

Owner / Operator Contact Address

1080 NW 163RD DRIVE, Miami Gardens, FL 33169, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K875069

PMA Number

N/A

All Registered Proprietary Names

AST/SGOT IDG Bilirubin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2013-01-14
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2009-03-09

Official Correspondent

Maria Sanchez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sanzay Corporation - Integrated Diagnostics Group

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852783	Advanced Biomedical Methods, Inc.	SGOT/ALT REAGENT	1985-07-22
K223078	Siemens Healthcare Diagnostics, Inc.	Atellica® CH Diazo Direct Bilirubin (D_DBil)	2023-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2015	ELITech Clinical Systems SAS Zone lndustrielle SEES France	2	ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Similar Registrations

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2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005146313. Last updated year: 2026. Please use registration number 3005146313 when referencing this establishment in official correspondence.