Product code KHW
- Device name
- Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3220
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170728 | E. HISTOLYTICA QUIK CHEK | Techlab, Inc. | 2017-06-07 |
| K994101 | E. HISTOLYTICA II | Techlab, Inc. | 1999-12-21 |
| K955895 | E. HISTOLYTICA TEST | Techlab, Inc. | 1996-08-30 |
| K954996 | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM | Trend Scientific, Inc. | 1996-08-08 |
| K944791 | ENTAMOEBA TEST | Techlab, Inc. | 1995-03-09 |
| K900604 | DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA | Biovir Laboratories, Inc. | 1990-07-26 |
| K890774 | GIARDEIA(TM) | Antibodies, Inc. | 1989-04-04 |
| K890003 | GIARDIA STOOL ANTIGEN TEST KIT | Lmd Laboratories | 1989-03-14 |
| K874849 | PROSPECT/GIARDIA | Alexon Biomedical, Inc. | 1988-01-05 |
| K870318 | AMEBIASIS ELISA TEST KIT | Lmd Laboratories | 1987-08-11 |
| K863811 | AMEBIASIS MICROASSAY | Diamedix Corp. | 1986-10-09 |
| K862473 | PDQ AMEBIASIS | Diamedix Corp. | 1986-08-01 |
| K854230 | MEBIASIS AGAR GEL DIFFUSION KIT | Lmd Laboratories | 1985-11-12 |
| K854017 | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) | Lmd Laboratories | 1985-10-22 |
| K853448 | HILLCREST AMEBIASIS IHA TEST | Hillcrest Biologicals | 1985-08-28 |
| K844141 | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) | Lmd Laboratories | 1984-12-06 |
| K831133 | AMEBIASIS BIO-ENZABEAD SCREEN KIT | Bionetic Laboratory Products | 1983-06-08 |
| K810046 | CORDIA A | Cordis Corp. | 1981-02-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| ENTIENTG01400 | NovaLisa Entamoeba histolytica IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| ENTIENTG0140 | NovaLisa Entamoeba histolytica IgG | Gold Standard Diagnostics Frankfurt GmbH | 2024-08-26 |
| 00894175000282 | AccuDiag ™ | Diagnostic Automation, Inc. | 2024-03-06 |
| 04048474038309 | Entamoeba histolytica IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474034745 | Entamoeba histolytica IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239038302 | Entamoeba histolytica IgG ELISA | DRG International Inc | 2023-08-25 |
| B350GSD0130130 | Entamoeba histolytica IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-11-18 |
| 07640158219652 | Fasciola hepatica IgG ELISA | Bordier affinity products S.A. | 2022-09-30 |
| 07640158219553 | Entamoeba histolytica IgG ELISA | Bordier affinity products S.A. | 2022-08-09 |
| 00083059070781 | E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2020-07-01 |
| 00857031002547 | TRI-COMBO PARASITE SCREEN | TECHLAB, INC. | 2019-05-31 |
| 00840239034748 | E. Histolytica IgG ELISA | DRG International Inc | 2019-03-20 |
| 00857031002400 | TRI-COMBO PARASITE SCREEN | TECHLAB, INC. | 2017-10-05 |
| 00857031002202 | E. HISTOLYTICA QUIK CHEK | TECHLAB, INC. | 2017-09-15 |
| 08305900070781 | E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2016-12-08 |
| 00857031002011 | E. HISTOLYTICA II | TECHLAB, INC. | 2016-08-23 |
| 00857031002349 | E. HISTOLYTICA II | TECHLAB, INC. | 2016-08-23 |