PAPP-A AccuLite CLIA Test System - 192 Wells

Basic Information

• Brand Name: PAPP-A AccuLite CLIA Test System - 192 Wells
• Primary DI: 00816870022659
• Version / Model: 12675-300
• Catalog Number: 12675-300B
• Company Name: MONOBIND, INC.
• Labeler DUNS: 083155515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-13
• Public Version: 1
• Public Version Date: 2024-09-23
• Public Version Status: New
• Public Device Record Key: 72a6252e-e059-4022-b34b-5447c7cf7432

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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
65862	Pregnancy-associated plasma protein-A2 (PAPP-A2) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of pregnancy-associated plasma protein A2 (PAPP-A2) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of pre-eclampsia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816870022659	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	7.75	Inch

Storage Conditions

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