Home › Device types › DHA
System, Test, Human Chorionic Gonadotropin
FDA product code DHA · Class 2 · Clinical Chemistry
77
Registered devices
3,570
Adverse events
14
Recalls
72
510(k) clearances
Devices with this code
Monobind AccuLite hCG CLIA Kit - 192 Wells — MONOBIND, INC.i-STAT — ABBOTT POINT OF CARE INC.Mosie Baby Pregnancy Test — GERMAINE LABORATORIES, INCIMMULITE® 2000 Systems HCG Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDBioStrip® P — PRINCETON BIOMEDITECH CORPORATIONStatus hCG card — PRINCETON BIOMEDITECH CORPORATIONAccess Total BhCG (5th IS) — Beckman Coulter, Inc.Elecsys HCG+beta — Roche Diagnostics GmbHIMMULITE® Systems HCG CONTROL HCG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDVITROS — ORTHO CLINICAL DIAGNOSTICSPregcolor Premium — GERMAINE LABORATORIES, INCPregcolor Plus — GERMAINE LABORATORIES, INCiFlash-HCG — Shenzhen YHLO Biotech Co., Ltd.Preview — WONDFO USA CO., LTD.ARCHITECT — ABBOTT IRELANDElecsys HCG Test System — Roche Diagnostics GmbHARCHITECT — ABBOTT IRELANDMcKesson — MCKESSON MEDICAL-SURGICAL INC.Free B-hCG XR AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.BioSign® hCG card — PRINCETON BIOMEDITECH CORPORATIONElecsys HCG Test System — Roche Diagnostics GmbHElecsys HCG+ beta — Roche Diagnostics GmbHIMMULITE®/IMMULITE® 1000 Systems HCG Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDBioStrip® P — PRINCETON BIOMEDITECH CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-24 | Abbott Laboratories | Reaction vessels may contain a potential contaminant that could affect their optical performance. |
| 2022-02-22 | Siemens Healthcare Diagnostics, Inc. | Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. |
| 2018-11-21 | Abbott Ireland Diagnostics Division | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Append |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2016-02-18 | Ortho-Clinical Diagnostics | When testing was conducted using certain lots, VITROS Systems generated results within the measuring range for samples known to not contain measurable hCG. The |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2006-04-03 | Dade Behring , Inc. | Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associa |
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