Pseudomonas-CF-IgG antigen pool, lyophilized 60899

GUDID 05713106608999

Human-antisera, Pseudomonas-CF-IgG

Ssi Diagnostica A/S

Pseudomonas aeruginosa antigen IVD, control
Primary Device ID05713106608999
NIH Device Record Key79421f39-d3ab-4870-8121-eeda22b91858
Commercial Distribution StatusIn Commercial Distribution
Brand NamePseudomonas-CF-IgG antigen pool, lyophilized
Version Model Number60899
Catalog Number60899
Company DUNS305684449
Company NameSsi Diagnostica A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105713106608999 [Primary]

FDA Product Code

GSSAntisera, Fluorescent, Pseudomonas Aeruginosa

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

Devices Manufactured by Ssi Diagnostica A/S

05713106994627 - Dermatophyte and C. albicans Real Time PCR kit2022-12-05 Intended use The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of
05713106105573 - ImmuView S. pneumoniae and L. pneumophila urinary antigen test2022-11-02 Urinary antigen test
05713106544013 - E. coli H4 serum, 5 mL2021-08-19 Rabbit antiserum, Ready to use
05713106544020 - E. coli H5 serum, 5 mL2021-08-19 Rabbit antiserum, Ready to use
05713106544044 - E. coli H6 serum, 5 mL2021-08-19 Rabbit antiserum, Ready to use
05713106544068 - E. coli H7 serum, 5 mL2021-08-19 Rabbit antiserum, Ready to use
05713106544075 - E. coli H8 serum, 5 mL2021-08-19 Rabbit antiserum, Ready to use
05713106544099 - E. coli H9 serum, 5 mL2021-08-19 Rabbit antiserum, Ready to use

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.