SICKLEDEX 217657

GUDID 00844509002048

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

STRECK, INC.

Haemoglobin S (HbS) IVD, control

• Primary Device ID: 00844509002048
• NIH Device Record Key: 8b5f3956-2b9e-492c-8ad2-59684b109768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SICKLEDEX
• Version Model Number: 217657
• Catalog Number: 217657
• Company DUNS: 072915986
• Company Name: STRECK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-228-6090
• Email: custserv@streck.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844509002048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023656

FDA Product Code

• GHM: Test, Sickle Cell

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [SICKLEDEX]

• 00844509002048: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b
• 00844509002031: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b
• 00844509002024: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b