Phadebact Pneumococcus Test

GUDID 07350049850122

Mkl Diagnostics AB

Streptococcus pneumoniae antigen IVD, kit, agglutination

• Primary Device ID: 07350049850122
• NIH Device Record Key: f043b54f-b931-4852-a766-dc7b216e99f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phadebact Pneumococcus Test
• Version Model Number: 10-5576-12
• Company DUNS: 350472667
• Company Name: Mkl Diagnostics AB
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: true

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350049850122 [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: 2018-09-20
• Device Publish Date: 2018-08-20

Devices Manufactured by Mkl Diagnostics AB

• 07350049850122 - Phadebact Pneumococcus Test: 2018-09-20
• 07350049850122 - Phadebact Pneumococcus Test: 2018-09-20
• 07350049850160 - Phadebact Streptococcus Test: 2018-09-20
• 07350049850177 - Phadebact Strep A Test: 2018-09-20
• 07350049850184 - Phadebact Strep B Test: 2018-09-20
• 07350049850191 - Phadebact Strep D Test: 2018-09-20
• 07350049850207 - Phadebact Strep F Test: 2018-09-20
• 07350049850214 - Phadebact Strep Positive Controls: 2018-09-20
• 07350049850238 - Phadebact CSF Positive Controls: 2018-09-20