E. coli OKO 114 reference strain 87255

GUDID 05713106872550

Reference strain

Ssi Diagnostica A/S

Escherichia coli antigen IVD, control Escherichia coli antigen IVD, control Escherichia coli antigen IVD, control Escherichia coli antigen IVD, control Escherichia coli antigen IVD, control Escherichia coli antigen IVD, control Escherichia coli antigen IVD, control

• Primary Device ID: 05713106872550
• NIH Device Record Key: 6332a260-f61b-4a61-9e6a-97a226fc646a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E. coli OKO 114 reference strain
• Version Model Number: 87255
• Catalog Number: 87255
• Company DUNS: 305684449
• Company Name: Ssi Diagnostica A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713106872550 [Primary]

FDA Product Code

• GMZ: ANTIGENS, ALL TYPES, ESCHERICHIA COLI

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-08-01

Devices Manufactured by Ssi Diagnostica A/S

• 05713106994627 - Dermatophyte and C. albicans Real Time PCR kit: 2022-12-05 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 test: 2022-11-02 Urinary antigen test
• 05713106544013 - E. coli H4 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use
• 05713106544020 - E. coli H5 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use
• 05713106544044 - E. coli H6 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use
• 05713106544068 - E. coli H7 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use
• 05713106544075 - E. coli H8 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use
• 05713106544099 - E. coli H9 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use