Wondview

GUDID 10816862021056

25-Strip; Strep A Throat Swab Test

WONDFO USA CO., LTD.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10816862021056
• NIH Device Record Key: 711ff772-c7a8-443b-acba-f56e6e0cbf36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wondview
• Version Model Number: W39-S
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com
• Phone: 6304682199
• Email: wondfo@wondfousa.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862021059 [Primary]
GS1	00816862028058 [Unit of Use]
GS1	10816862021056 [Package]; Contains: 00816862021059; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133343

FDA Product Code

• GTY: Antigens, All Groups, Streptococcus Spp.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-14
• Device Publish Date: 2018-12-12

Devices Manufactured by WONDFO USA CO., LTD.

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• 00810174470918 - PRIME SCREEN®: 2025-12-15 Prime Screen® 6-Panel Card; 2 per box; AMP,BZO,COC,MET,OPI,THC
• 00810174470956 - PRIME SCREEN®: 2025-12-15 6-Panel T-Swab; AMP-COC-OPI;MET-THC-OXY, 5Test/ Box
• 00810174470970 - PRIME SCREEN®: 2025-12-15 14-Panel T-Cup 10 per Box; AMP,BAR,BUP,BZO,CO C,MET,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
• 00810174470994 - PRIME SCREEN®: 2025-12-15 Prime Screen® 6 panel T-swab, AMP,COC,OPI,MET,THC,PCP; 5 per box
• 00810174471014 - SAFElife™: 2025-12-15 SAFElife™ 1-Panel Card; BUP Buprenorphine