WHOLE BLOOD ETHANOL CONTROL LEVEL 2

Basic Information

• Brand Name: WHOLE BLOOD ETHANOL CONTROL LEVEL 2
• Primary DI: 00817238011575
• Version / Model: 93212
• Company Name: CLINIQA CORPORATION
• Labeler DUNS: 078742335
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-23
• Public Version: 3
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 927c6c16-1107-44f4-b221-6453d22213e9

Device Description

WHOLE BLOOD ETHANOL CONTROL LEVEL 2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
DKC	Alcohol Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47869	Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817238011575	GS1

Premarket Submissions

Submission Number	Supplement Number
K912826	000