Xpert Nasopharyngeal Sample Collection Kit

Basic Information

• Brand Name: Xpert Nasopharyngeal Sample Collection Kit
• Primary DI: 07332940002565
• Version / Model: SWAB/B-100
• Catalog Number: SWAB/B-100
• Company Name: CEPHEID
• Labeler DUNS: 956711444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-02
• Public Version: 2
• Public Version Date: 2023-01-26
• Public Version Status: Update
• Public Device Record Key: 944100d9-6cf6-4142-9097-09394e8979f8

Device Description

Xpert Nasopharyngeal Sample Collection Kit; 100 pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSM	Culture Media, Non-Propagating Transport	Microbiology	866.2390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62773	General specimen collection kit IVD, clinical	A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332940002565	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171552	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius