QuikStrip

GUDID 10748349000233

QuikStrip OneStep hCG Test

SYNTRON BIORESEARCH, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10748349000233
• NIH Device Record Key: 84f558a4-07d5-479c-b09e-b3c2980fce1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikStrip
• Version Model Number: 9020
• Company DUNS: 174517060
• Company Name: SYNTRON BIORESEARCH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00748349000236 [Primary]
GS1	10748349000233 [Package]; Contains: 00748349000236; Package: Kit Box [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921099

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2016-12-09

On-Brand Devices [QuikStrip]

• 20748349000360: DDS 5 Test COC 300, MET 1000, OPI 300, TCA 1000, THC 50
• 10748349000233: QuikStrip OneStep hCG Test