p53

Basic Information

• Brand Name: p53
• Primary DI: 00847627033956
• Version / Model: ALI298G7
• Company Name: BIOCARE MEDICAL LLC
• Labeler DUNS: 806617825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-14
• Public Version: 1
• Public Version Date: 2023-03-22
• Public Version Status: New
• Public Device Record Key: 17442dac-072d-4a26-8fce-d7a2cfd87e24

Device Characteristics

• Single Use: No
• 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: Yes
• 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
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57514	p53 tumour protein IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of p53 tumour protein in a clinical specimen, using an enzyme immunohistochemistry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847627033956	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius