PIN 4 COCKTAIL - AM448-5M
Device Description
Multiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple markers potentially associated with prostate cancer in a clinical specimen. Examples of detectable markers include prostatic intraepithelial neoplasia markers (e.g., cytokeratin HMW), prostate specific antigen (PSA), alpha-methylacyl-CoA racemase (AMACR), and p63 tumour protein.
Environmental Conditions
- Store at 2-8°C
Device Sizes
- Total Volume: 6 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NJT
Device Name: Immunohistochemistry Reagents And Kits
Device Class: 1
Physical State: N/A
Definition: according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
Submission Type ID: 4
Review Panel: PA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.1860
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 00810119671806
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A