Wondfo Key Cup KDOA-254

GUDID 10816862020004

5-Panel Key Cup; AMP,COC,mAMP,OPI,THC

WONDFO USA CO., LTD.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10816862020004
• NIH Device Record Key: feabf720-b922-433e-8a5f-cb61529a829f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wondfo Key Cup
• Version Model Number: KDOA-254
• Catalog Number: KDOA-254
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 25
• 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

Customer Support Contacts

• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862020007 [Primary]
GS1	00816862029000 [Unit of Use]
GS1	10816862020004 [Package]; Contains: 00816862020007; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130665

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

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: 2016-09-20

On-Brand Devices [Wondfo Key Cup]

• 00816862025040: 10-Panel Key Cup; BAR,BZO,BUP,COC,mAMP,MTD,OPI,OXY,TCA,THC
• 00816862025033: 10-Panel Key Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
• 00816862025026: 7-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
• 00816862025019: 6-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,THC
• 00816862025002: 5-Panel Key Cup; AMP,COC,mAMP,OPI,THC
• 10816862020042: 10-Panel Key Cup; BAR,BZO,BUP,COC,mAMP,MTD,OPI,OXY,TCA,THC
• 10816862020035: 10-Panel Key Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
• 10816862020028: 7-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
• 10816862020011: 6-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,THC
• 10816862020004: 5-Panel Key Cup; AMP,COC,mAMP,OPI,THC