Hologic PRD-08396

GUDID 15420045517394

NG Res Primers Analyte Specific Reagent.

Hologic, Inc.

Multiple-genus sexually transmitted bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15420045517394
• NIH Device Record Key: 1b83a00c-c7af-4631-a89b-3b62b51d7863
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hologic
• Version Model Number: RNA, NG RES PRIMERS (ASR)
• Catalog Number: PRD-08396
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -85 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045517394 [Primary]

FDA Product Code

• MVU: Reagents, specific, analyte

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: 2025-09-05
• Device Publish Date: 2025-08-28

On-Brand Devices [Hologic]

• 15420045512610: COV NL63 PROBE (ASR)
• 15420045512603: COV 229E PROBE (ASR)
• 15420045512597: COV OC43 PROBE (ASR)
• 15420045512580: COV HKU1 PROBE (ASR)
• 15420045512573: COV NL63 PRIMERS (ASR)
• 15420045512566: COV 229E PRIMERS (ASR)
• 15420045512559: COV OC43 PRIMERS (ASR)
• 15420045512542: COV HKU1 PRIMERS (ASR)
• 15420045517424: NG IVT Wild Type Control (Negative Control).
• 15420045517417: NG Res C272T IVT Control (Positive Control).
• 15420045517400: NG Res Probe (FAM) Analyte Specific Reagent.
• 15420045517394: NG Res Primers Analyte Specific Reagent.