SICKLEDEX

Basic Information

• Brand Name: SICKLEDEX
• Primary DI: 00844509002048
• Version / Model: 217657
• Catalog Number: 217657
• Company Name: STRECK, INC.
• Labeler DUNS: 072915986
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8b5f3956-2b9e-492c-8ad2-59684b109768

Device Description

A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 100 tests.

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: Yes
• 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
GHM	Test, Sickle Cell	Hematology	864.7825	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56232	Haemoglobin S (HbS) 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 haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844509002048	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023656	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius