Poly Rb a Hu Alpha-1-Antitrypsin

Basic Information

• Brand Name: Poly Rb a Hu Alpha-1-Antitrypsin
• Primary DI: 05700572000273
• Version / Model: A0012
• Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD
• Labeler DUNS: 894671143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 7
• Public Version Date: 2020-12-07
• Public Version Status: Update
• Public Device Record Key: 12a0a9e4-9a10-4c12-9e51-7416f9d39b4f

Device Description

Polyclonal Rabbit Anti-Human Alpha-1-Antitrypsin

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
DEW	IGG, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62767	Alpha-1-antitrypsin (protease inhibitor) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700572000273	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	2	Milliliter

Storage Conditions

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