FDA Device Registration & Listing · Bedford, MA, US · Registration 3016609999
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LNW | Paper, Obstetric Ph | Clinical Chemistry | Class 1 | 862.1550 | 2023-08-14 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2024-09-19 |
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Clinical Chemistry | Class 1 | 862.1300 | 2024-09-23 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2024-03-05 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2024-03-05 |
| KHE | Reagent, Occult Blood | Hematology | Class 2 | 864.6550 | 2023-11-28 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-08-31 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2023-08-31 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2023-08-31 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2023-08-31 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2023-10-31 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2023-10-31 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | Clinical Chemistry | Class 1 | 862.1485 | 2024-09-19 |
| QKE | Immunoassay, Pregnanediol Glucuronide, Over The Counter | Clinical Chemistry | Class 1 | 862.1620 | 2024-09-23 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2024-05-09 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2024-05-09 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Microbiology | Class 2 | 866.3987 | 2025-05-13 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2023-10-31 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2023-10-31 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2023-10-31 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2023-10-31 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | Class 2 | 862.3910 | 2023-10-31 |
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | Class 2 | 862.3700 | 2023-10-31 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2023-10-31 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2023-10-31 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2023-10-31 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2023-10-31 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2023-10-31 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K964108 | Direct Access Diagnostics | FACT PLUS PREGNANCY TEST | 1996-11-18 |
| K945514 | Princeton BioMeditech Corp. | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG | 1995-02-10 |
| K150022 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | 2015-08-07 |
| K043443 | Guangzhou Wondfo Biotech Co., Ltd. | ONE STEP HCG URINE PREGNANCY TEST | 2005-04-08 |
| K173229 | Guangzhou Wondfo Biotech Co., Ltd. | Preview Digital Pregnancy Test | 2018-03-12 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-04 | Instrumentation Laboratory Co. | 1 | Lactate Disposable Membrane Caps
Product Number: 0018108400 |
| Z-0042-2024 | Universal Meditech Inc. | 2 | One Step Pregnancy Test REF 100-01 |
| Z-0006-2010 | Biosite Inc | 2 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0007-2010 | Biosite Inc | 2 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0008-2010 | Biosite Inc | 2 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3024676893 | PANGAEA TECHNOLOGIES LLC | The Woodlands, TX, US |
| 3021595883 | XIAMEN MK HEALTH CARE PRODUCT CO., LTD. | XIAMEN Fujian, CN |
| 3016621374 | Jiangsu Medomics Medical Technology Co., Ltd. | Nanjing Jiangsu, CN |
| 3025041446 | 2SAN LLC | New York, NY, US |
| 3005630901 | FridaBaby LLC | Miami, FL, US |
3016609999 when referencing this establishment in official correspondence.