Wondfo
GUDID 00816862022216
1-Strip; hCG Pregnancy Test SCI
WONDFO USA CO., LTD.
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00816862022216 |
| NIH Device Record Key | 868f9e52-00dc-4b6b-a483-e5f0172c49b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wondfo |
| Version Model Number | SW1-S |
| Company DUNS | 849098897 |
| Company Name | WONDFO USA CO., LTD. |
| Device Count | 100 |
| 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 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 4 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816862022216 [Primary] |
| GS1 | 00816862022223 [Unit of Use] |
| GS1 | 10816862022213 [Package] Package: [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043443
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2019-12-28 |
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 |
Trademark Results [Wondfo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WONDFO 98185800 not registered Live/Pending |
Guangzhou Lerui Biotechnology Co., Ltd 2023-09-19 |
 WONDFO 90761697 not registered Live/Pending |
GUANGZHOU WONDFO BIOTECH CO., LTD. 2021-06-08 |
 WONDFO 79289867 not registered Live/Pending |
GUANGZHOU WONDFO BIOTECH. CO., LTD. 2020-04-15 |
 WONDFO 79146032 4737093 Live/Registered |
GUANGZHOU WONDFO BIOTECH CO., LTD. 2014-02-11 |
 WONDFO 79076656 3889338 Live/Registered |
GUANGZHOU WONDFO BIOTECH CO., LTD. 2009-11-11 |
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