MAXCHECK CPT01

GUDID 20852359007049

One Step Pregnancy (HCG) Urine Test Strip

MAXPERT MEDICAL

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 20852359007049
• NIH Device Record Key: 962cda23-2550-426f-bbcd-60a80540e71a
• Commercial Distribution Discontinuation: 2018-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MAXCHECK
• Version Model Number: CPT01
• Catalog Number: CPT01
• Company DUNS: 066886996
• Company Name: MAXPERT MEDICAL
• 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852359007045 [Primary]
GS1	10852359007042 [Package]; Contains: 00852359007045; Package: [5 Units]; Discontinued: 2018-12-12; Not in Commercial Distribution
GS1	20852359007049 [Package]; Contains: 10852359007042; Package: [25 Units]; Discontinued: 2018-12-12; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132085

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: 4
• Public Version Date: 2018-12-14
• Device Publish Date: 2017-12-19

On-Brand Devices [MAXCHECK]

• 10852359007066: 12 Panel Rapid Multi-Drug Test Cup
• 20852359007049: One Step Pregnancy (HCG) Urine Test Strip