LA Control Low

Basic Information

• Brand Name: LA Control Low
• Primary DI: 00630414023502
• Version / Model: 10873569
• Catalog Number: OQWE13
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 6
• Public Version Date: 2024-02-21
• Public Version Status: Update
• Public Device Record Key: bfca4c95-6d99-4c22-83fa-881dcae24894

Device Description

LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays

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
GGC	CONTROL, PLASMA, ABNORMAL	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46029	Lupus anticoagulant marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414023502	GS1
Unit of Use	00842768019678	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K993332	000

Storage Conditions

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