ImmuLex Pneumococcus Pool S serum, 1.5 mL 52402

GUDID 05713106524022

Rabbit antiserum, Ready to use

Ssi Diagnostica A/S

Streptococcus pneumoniae culture isolate antigen IVD, antibody

• Primary Device ID: 05713106524022
• NIH Device Record Key: 23c87286-3c5e-474b-8903-2fac242a87cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmuLex Pneumococcus Pool S serum, 1.5 mL
• Version Model Number: 52402
• Catalog Number: 52402
• 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
• Phone: +4548299100
• Email: info@ssidiagnostica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713106524022 [Primary]

FDA Product Code

• GWC: ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE

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: 2021-08-02
• Device Publish Date: 2021-07-25

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• 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