PAP
IMMULITE®/IMMULITE® 1000 Systems PAP - 10380953
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of prostatic acid phosphatase (PAP) in a clinical specimen, using a chemiluminescent immunoassay method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JFH
Device Name: Acid Phosphatase (Prostatic), Tartrate Inhibited
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
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: 862.1020
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00630414964355
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