RESPDIRECT™ PRD-07788

GUDID 15420045516694

RespDirect™ Collection Kit, 50 count.

Hologic, Inc.

Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical Oral/upper respiratory tract specimen collection kit IVD, clinical

• Primary Device ID: 15420045516694
• NIH Device Record Key: 3132ba3a-df1b-4a37-ad25-a89d1960b228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESPDIRECT™
• Version Model Number: RESPDIRECT COLLECTION KIT, US-KIT, BOX
• Catalog Number: PRD-07788
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 50
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045516694 [Unit of Use]
GS1	25420045516691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222736

FDA Product Code

• QOF: Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

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: 2023-08-22
• Device Publish Date: 2023-08-14

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