Wondfo

GUDID 10816862024101

Nucleic Acid Extraction Kit: 96 Tests/Kit (96 Samples per Plate), 1 Sample Plate,3 Prefilled Reagent Plates,1 sealed vial with Proteinase K

WONDFO USA CO., LTD.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 10816862024101
• NIH Device Record Key: 495b5d65-2d3c-4670-b476-866d29b992a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wondfo
• Version Model Number: WE03P0014
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 96
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com
• Phone: 630-468-2272
• Email: wondfo@wondfousa.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862024104 [Primary]
GS1	00816862024111 [Unit of Use]
GS1	10816862024101 [Package]; Contains: 00816862024104; Package: [18 Units]; In Commercial Distribution

FDA Product Code

• JJH: Clinical Sample Concentrator

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: 2023-08-21
• Device Publish Date: 2023-08-11

On-Brand Devices [Wondfo]

• 10816862021629: 12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC with 3 AD
• 00816862021615: 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test
• 10816862021513: 25-Strip; hCG Pregnancy Test 10mIU
• 10816862021346: 25-Strip; hCG Pregnancy Test
• 10816862021315: 5-Panel Card for Cup; AMP,COC,mAMP,OPI,THC with 3 AD (OX,SG,pH)
• 10816862021308: 12-Panel Card for Cup; AMP,BAR,BUP,BZO,COC,MDMA,MTD,TCA,OPI,OXY,PCP,THC
• 10816862021254: 5-Panel Card for Cup; AMP,COC,mAMP,OPI,THC
• 00816862021233: 10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,THC
• 10816862021223: 10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
• 00816862021219: 12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
• 10816862021209: 5-Panel T-Cup Compact; AMP,COC,mAMP,OPI,THC
• 00816862021066: 12-Panel CR3 Split Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
• 10816862020950: 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test
• 10816862020943: 20-Strip; hCG Pregnancy Test
• 10816862022336: 24-Strips; Alcohol Saliva Test Box 24 Pcs
• 00816862022162: 1-Panel Cassette; hCG Pregnancy Test SCI
• 00816862021929: 1 Strip; hCG Serum/Urine Test Strip
• 10816862023272: 9-Panel Card without THC; AMP,BAR,BUP,BZO,COC,MET,MTD,OPI,OXY
• 10816862023258: 1-Strip; THC Marijuana/Cannabinoids
• 10816862023234: 11-Panel Card; AMP/BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/THC/EDDP
• 10816862023166: 2-Panel T-Swab; AMP-COC-OPI; MET-THC-PCP
• 10816862023142: 2-Panel T-Swab; AMP-COC-OPI; MET-THC-OXY
• 10816862023128: 2-Panel T-Swab; AMP-MTD-COC; MET-THC-OPI
• 10816862023104: 2-Panel T-Swab; AMP-MDMA-COC; MET-THC-OPI
• 10816862023012: 100-Strips; Alcohol Saliva Test Box 100 Pcs
• 10816862022992: 25-Strips; Alcohol Saliva Test Box 25 Pcs
• 10816862022930: 1-Strip; LH Semi Quantitative Ovulation Test
• 00816862022827: 1-Strip; LH Ovulation Test
• 10816862023692: 1-Strip; LH Ovulation Test
• 00816862022216: 1-Strip; hCG Pregnancy Test SCI
• 10816862023920: 1-Strip; hCG Pregnancy Test
• 10816862024040: hCG pregnancy test strip, 10mIU Cut-Off, 5mm strip width, 25T/Box
• 10816862023821: 1-Midstream; hCG Pregnancy Midstream Test
• 10816862023807: 1-Cassette; hCG Pregnancy Test 25 mIU/mL CLIA Waived
• 10816862022756: PREGNANCY MIDSTREAM TEST
• 10816862024101: Nucleic Acid Extraction Kit: 96 Tests/Kit (96 Samples per Plate), 1 Sample Plate,3 Prefilled Rea
• 10816862024224: Wondfo hCG Pregnancy Test, 25mIU/ml
• 10816862024323: 1-Midstream DoCheck Wide Tip;1 per box;hCG Pregnancy Test 25 mIU/mL OTC
• 10816862024538: 10-Strips; Alcohol Saliva Test Box 10 Pcs
• 10816862024347: 1-Panel Cassette; LH Ovulation Test SCI
• 00816862024470: Prime Screen® Multi-Drug Urine Test Cup(12-Panel C-Cup: BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,P
• 10816862024378: 10-Strip HCG Pregnancy Tests,40-Strip LH-Ovulation Test, and 50 Plastic Urine Cups
• 10816862024354: 5-Strip HCG Pregnancy Tests,20-Strip LH-Ovulation Test, and 25 Plastic Urine Cups