BD PrepStain

Basic Information

• Brand Name: BD PrepStain
• Primary DI: 00382904905217
• Version / Model: 490521
• Catalog Number: 490521
• Company Name: TRIPATH IMAGING, INC.
• Labeler DUNS: 103318015
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c6e878a7-1fa0-4e9f-a794-66167b0e6352
• Distribution End Date: 2015-08-26

Device Description

PrepStain® Density Reagent

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MKQ	Processor, Cervical Cytology Slide, Automated	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
12955	Papanicolaou smear kit	A packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904905217	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970018	001

Device Sizes

Type	Value	Unit	Text
Height	21.7	Centimeter
Width	10.9	Centimeter
Length	10.9	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius