SSI Diagnostica A/S

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9611882	3002808078	SSI Diagnostica A/S	1	N	2026-01-01	2 Herredsvejen Hilleroed Hovedstaden DK 3400

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
05713106850046	E. coli O8 serum, 1 mL - Rabbit antiserum, Ready to use	+4548299100	info@ssidiagnostica.com
05713106850053	E. coli O9 serum, 1 mL - Rabbit antiserum, Ready to use	+4548299100	info@ssidiagnostica.com

ssidiagnostica.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
198896	1853908417	K191184	ImmuView S pneumoniae and L pneumophila Urinary Antigen Test	MJH	2020-03-05
198896	1017479896
198896	1059965271
198896	1075873898
198896	1181358301
198896	1188799861
198896	1327252099
198896	1344201772
198896	1408885195
198896	1624077168
198896	1747681876
198896	1810618767
198896	1831125051
198896	2018418482
198896	1677387837

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MJH	2	2020-03-05

PMN#

ImmuView S Pneumoniae And L Pneumophila Urinary Antigen Test
2020-03-05
SSI Diagnostica A/S

GUDID#

E. coli O8 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O9 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O26 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O45 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O88 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O103 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O104 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O111 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O121 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O139 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O141 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O145 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O149 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O157 serum, 1 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-11
E. coli O1 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O2 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O5 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O6 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O55 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O78 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O86 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O90 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O91 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O101 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O113 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O118 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O119 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O126 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O127 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O138 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O142 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O146 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O158 serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O125abc serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
E. coli O128abc serum, 3 mL - Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
2021-08-02
Pneumococcus Factor 18c serum high titer, 1 mL - Rabbit antiserum, High titer
Ssi Diagnostica A/S
2021-08-01
Pneumococcus Factor 10d serum high titer, 1 mL - Rabbit antiserum, High titer
Ssi Diagnostica A/S
2021-08-01
Pneumococcus Factor 11c serum high titer, 1 mL - Rabbit antiserum, High titer
Ssi Diagnostica A/S
2021-08-01
Pneumococcus Factor 33b serum high titer, 1 mL - Rabbit antiserum, High titer
Ssi Diagnostica A/S
2021-08-01
Pneumococcus Factor 12b serum high titer, 1 mL - Rabbit antiserum, High titer
Ssi Diagnostica A/S
2021-08-01

200 records. Showing 1-40. Next