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

• 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

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

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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• 10816862022756 - Wondfo: 2023-08-11 PREGNANCY MIDSTREAM TEST
• 10816862023036 - T-Dip: 2023-08-11 3-Panel Card;COC300,OPI2000,THC50
• 10816862023722 - Preview: 2023-08-11 10-Strip; Strep A Throat Swab Test
• 10816862023760 - Prime Screen: 2023-08-11 1-Panel Card; 25 per box; One Step THC Urine Test
• 10816862023784 - Preview: 2023-08-11 25-Strips;Preview hCG Early Result Pregnancy Test Strip 10 mIU/mL CLIA Waived
• 10816862023807 - Wondfo: 2023-08-11 1-Cassette; hCG Pregnancy Test 25 mIU/mL CLIA Waived