Product code GMZ
- Device name
- Antigens, All Types, Escherichia Coli
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3255
- 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 |
|---|---|---|---|
| K222829 | Curian® Shiga Toxin | Meridian Bioscience, Inc. | 2023-04-17 |
| K121364 | SHIGA TOXIN QUIK CHEK | Techlab Inc., Corporate Research Center | 2012-10-02 |
| K121411 | SHIGA TOXIN CHEK | Techlab Inc., Corporate Research Center | 2012-10-02 |
| K062546 | IMMUNOCARD STAT! EHEC, MODEL 751630 | Meridian Bioscience, Inc. | 2007-02-14 |
| K061889 | BIOSTAR OIA SHIGATOX | Inverness Medical-Biostar, Inc. | 2006-12-12 |
| K023599 | IMMUNOCARD STAT! E. COLI O157 PLUS | Meridian Bioscience, Inc. | 2003-01-03 |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | Meridian Diagnostics, Inc. | 1999-08-09 |
| K980507 | PROSPECT SHIGA TOXIN MICROPLATE ASSAY | Alexon - Trend, Inc. | 1998-04-23 |
| K973457 | CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 | Shared Systems, Inc. | 1998-01-02 |
| K971663 | WELLCOLEX E.COLI O157:H7 | Murex Biotech , Ltd. | 1997-12-30 |
| K972156 | QUIX RAPID E. COLI O157 STRIP TEST | Guardian Scientific, Corp. | 1997-10-16 |
| K942705 | E. COLI 0157 ELISA STOOL ASSAY | Lmd Laboratories | 1995-09-27 |
| K944421 | E.COLI 0157 LATEX TEST | Pro-Lab Diagnostics | 1994-12-15 |
| K884513 | PF TEST | Medi-Tech, Inc. | 1989-02-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840733103308 | Curian Shiga Toxin | MERIDIAN BIOSCIENCE, INC. | 2023-05-26 |
| 05713106818626 | E. coli reference strain O26 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818619 | E. coli reference strain O25 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818602 | E. coli reference strain O24 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818596 | E. coli reference strain O23 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818589 | E. coli reference strain O22 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818572 | E. coli reference strain O21 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818565 | E. coli reference strain O20 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818558 | E. coli reference strain O19ab | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818541 | E. coli reference strain O18ac | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818510 | E. coli reference strain O18ab | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818503 | E. coli reference strain O17 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818497 | E. coli reference strain O16 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818480 | E. coli reference strain O15 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818473 | E. coli reference strain O14 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818466 | E. coli reference strain O13 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818459 | E. coli reference strain O12 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818442 | E. coli reference strain O11 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818435 | E. coli reference strain O10 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818428 | E. coli reference strain O9 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818411 | E. coli reference strain O8 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818404 | E. coli reference strain O7 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818398 | E. coli reference strain O6 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818381 | E. coli reference strain O5 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818350 | E. coli reference strain O4 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818343 | E. coli reference strain O3 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818336 | E. coli reference strain O2 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818329 | E. coli reference strain O1 | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106818299 | E. coli reference strain O187 | Ssi Diagnostica A/S | 2021-08-01 |
| 05056080501895 | Wellcolex E.coli O157:H7 | REMEL EUROPE LIMITED | 2021-07-21 |