GROUP A STREPTOCOCCUS 103890B

GUDID 15420045506312

Hologic, Inc.

Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15420045506312
• NIH Device Record Key: f81bb815-76b2-4a58-8c82-b2473614a9c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GROUP A STREPTOCOCCUS
• Version Model Number: GROUP A STREP DIRECT TEST (GASD) 500T
• Catalog Number: 103890B
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045506312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924715

FDA Product Code

• MDK: DNA-PROBE, REAGENTS, STREPTOCOCCAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-02

On-Brand Devices [GROUP A STREPTOCOCCUS]

• 15420045506312: GROUP A STREP DIRECT TEST (GASD) 500T
• 15420045506305: GROUP A STREP DIRECT TEST (GASD) 100T