E. coli OKO 157 reference strain 87257

GUDID 05713106872574

Reference strain

Ssi Diagnostica A/S

Escherichia coli antigen IVD, control

• Primary Device ID: 05713106872574
• NIH Device Record Key: 878d8b45-2afc-41f7-999d-918bd70a8f23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E. coli OKO 157 reference strain
• Version Model Number: 87257
• Catalog Number: 87257
• 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	05713106872574 [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