Specific Diagnostics

FDA Device Registration & Listing · San Jose, CA, US · Registration 3023036790

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023036790
FEI Number
3023036790
Entity Name
Specific Diagnostics
City/State/Country
San Jose, CA, US
Establishment Address
130 Baytech Dr, San Jose, CA 95134, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
BIOMERIEUX SA (Owner Number: 8020790)
Owner / Operator Contact Address
Chemin De L Orme, Marcy L Etoile, FR-69 69280, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230675
PMA Number
N/A

All Registered Proprietary Names

VITEK REVEAL GN01-AST VITEK REVEAL Sealer VITEK REVEAL Sensor Panel VITEK REVEAL BC GN02-AST VITEK REVEAL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Microbiology Class 2 866.1645 2008-04-30
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Microbiology Class 2 866.1645 2024-07-31
SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Microbiology Class 2 866.1650 2024-07-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOMERIEUX SA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1450405 BIOMERIEUX, INC. LOMBARD, IL, US
3025775667 BIOMERIEUX, INC. Salt Lake City, UT, US
3008249922 BIOMERIEUX SA - Grenoble Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR
3009307598 BIOMERIEUX SPAIN Tres Cantos Madrid (Province), ES
9615778 BioMerieux SA VERNIOLLE Ariege, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033458 Becton, Dickinson & CO BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST 2004-05-28
K112000 bioMerieux, Inc. VITEK 2 STREPTOCOCCUS PENICILLIN 2011-10-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0170-2015 Siemens Healthcare Diagnostics, Inc. 2
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

Similar Registrations

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1119779 BECTON, DICKINSON & CO. SPARKS, MD, US
3031977134 bioMerieux, Inc. Morrisville, NC, US
1950204 BIOMERIEUX, INC. HAZELWOOD, MO, US
3007502289 Laboratorios PiSA, S. A. de C.V. Tlajomulco de Zuniga Jalisco, MX
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023036790. Last updated year: 2026. Please use registration number 3023036790 when referencing this establishment in official correspondence.
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