Coatest APCR Control Plasma Level 1

Basic Information

• Brand Name: Coatest APCR Control Plasma Level 1
• Primary DI: 08426950088912
• Version / Model: 82 2650 63
• Catalog Number: 82 2650 63
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2021-07-14
• Public Version Status: Update
• Public Device Record Key: 17a3b13e-1d9a-4b88-b345-33c3d8a49fd4

Device Description

Coatest APCR Control Plasma Level 1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
GGW	TEST, TIME, PARTIAL THROMBOPLASTIN	Hematology	864.7925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950088912	GS1
Unit of Use	18426950088919	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K945940	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.