E. coli OKO 55 reference strain 87259

GUDID 05713106872598

Reference strain

Ssi Diagnostica A/S

Escherichia coli antigen IVD, control
Primary Device ID05713106872598
NIH Device Record Keyeee8a32a-28c1-4726-b2b5-5549fd827cd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameE. coli OKO 55 reference strain
Version Model Number87259
Catalog Number87259
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

Customer Support Contacts

Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105713106872598 [Primary]

FDA Product Code

GMZANTIGENS, ALL TYPES, ESCHERICHIA COLI

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-09
Device Publish Date2021-08-01

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

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