Changchun Wancheng Bio-Electron Co., Ltd.
Changchun Jilin, CN
CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD. appears in FDA device records in Changchun Jilin, CN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008987086 | 3008987086 | CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD. | No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin, Changchun Jilin 130000 CN | 2026 | and 24 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- KNKAcid, Uric, Uricase (Colorimetric)
- GNAAntisera, All Types, Escherichia Coli
- GOOAntisera, Fluorescent, All Globulins, Salmonella Spp.
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JLAConversion To Creatinine, Creatine
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- LAFGas Chromatography, Methamphetamine
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- JXAKit, Screening, Urine
- NRFMaterial, Quality Control, Semen Analysis
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- LNWPaper, Obstetric Ph
- JRSPurifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
- JNQQualitative Chemical Reactions, Urinary Calculi (Stone)
- KSLSolution, Copper Sulfate For Specific Gravity Determinations
- IGDSolution, Formol Calcium
- DFQSperm, Antigen, Antiserum, Control
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- LJXTest, Urine Leukocyte
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1267-2026 | Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1266-2026 | Vivoo Vaginal pH Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1265-2026 | Vivoo Protein Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1264-2026 | Vivoo pH Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1263-2026 | Exploro Highly Sensitive Male Fertility / Sperm Concentration Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1262-2026 | Male Fertility Sperm Test for Home Use (Cassette) | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1261-2026 | S. Typhi/Para Typhi A Antigen | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1260-2026 | Menopause Test Cassette (Urine) | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1259-2026 | LH One Step Ovulation Test Device (Urine) | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1258-2026 | The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified | |
| Z-1257-2026 | LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI) | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain