Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611882

FEI Number

3002808078

Entity Name

SSI Diagnostica A/S

City/State/Country

Hilleroed Hovedstaden, DK

Establishment Address

2 Herredsvejen, Hilleroed Hovedstaden 3400, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SSI Diagnostica A/S (Owner Number: 10052749)

Owner / Operator Contact Address

Herredsvejen 2, Hilleroed, DK-84 3400, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pneumococcus strain S. pneumoniae strain Streptococcus strain E. coli Reagent Pneumococcus ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test Salmonella Streptococcus E.coli strain

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2016-09-27
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2016-09-27
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2016-09-27
GWC	Antisera, All Types, Streptococcus Pneumoniae	Microbiology	Class 1	866.3740	2016-09-27
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2020-03-06
MJH	Legionella, Spp., Elisa	Microbiology	Class 2	866.3300	2020-03-06
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2016-09-27
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2016-09-27
GMZ	Antigens, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2016-09-27

Official Correspondent

Marianne Thorsen

US Agent Details

Donna Link Business: Techlab Inc. Email: regulatory@techlab.com Phone: (540) 9531664

Related Public Records

Same Entity

SSI Diagnostica A/S

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
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31

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3004635103	GUANGZHOU WONDFO BIOTECH CO., LTD.	Guangzhou Guangdong, CN
3017772438	Sekisui Diagnostics, LLC	San Diego, CA, US
3005360469	ACRO BIOTECH Inc.	Montclair, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611882. Last updated year: 2026. Please use registration number 9611882 when referencing this establishment in official correspondence.