Product code GNA
- Device name
- Antisera, 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 |
|---|---|---|---|
| K071799 | MODIFICATION TO BIOSTAR OIA SHIGATOX | Iverness Medical Professional Diagnostics | 2007-10-02 |
| K031367 | DUOPATH VEROTOXINS GLISA TEST | Emd Chemicals, Inc. | 2004-01-23 |
| K993401 | DRYSPOT E.COLI 0157 KIT | Oxoid , Ltd. | 2000-02-28 |
| K981734 | VTEC-RPLA SEIKEN | Denka Seiken'S | 1998-09-22 |
| K962028 | WELLCOLEX E-COLI OI57 ZC60 | Murex Diagnostics, Inc. | 1996-11-01 |
| K953362 | PREMIER EHEC | Meridian Diagnostics, Inc. | 1995-11-14 |
| K950167 | PREMIER EHEC | Meridian Diagnostics, Inc. | 1995-04-14 |
| K933457 | RIM E.COLI 0157:H7 LATEX TEST | Remel Co. | 1994-04-20 |
| K903714 | E. COLI 0157 LATEX TEST | Pro-Lab, Inc. | 1991-01-24 |
| K884026 | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT | Oxoid U.S.A., Inc. | 1989-02-03 |
| K874288 | PHADEBACT ETEC-LT TEST | Pharmacia, Inc. | 1988-09-02 |
| K855234 | DIAGNOSTIC REAGENT VET-RPLA | Oxoid U.S.A., Inc. | 1986-11-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10628429001056 | Prolex E. coli O157 Latex Test Reagent Kit (100 tests) | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001100 | Prolex E. coli O157 Latex Reagent Control Negative | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001124 | Prolex E. coli Non-O157 Identification Kit | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001131 | Prolex E. coli O26 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001148 | Prolex E. coli O45 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001155 | Prolex E. coli O103 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001162 | Prolex E. coli O111 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001179 | Prolex E. coli O121 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001186 | Prolex E. coli O145 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001193 | Prolex E. coli Non-O157 Negative Control Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001209 | Prolex E. coli O91 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001216 | E. coli O157 Antiserum (3ml) | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001049 | Prolex E. coli O157 Latex Test Reagent Kit (50 tests) | PRO-LAB, INCORPORATED | 2022-12-26 |
| 00848838026768 | REMEL | REMEL, INC. | 2022-12-23 |
| 05032384028511 | VET-RPLAKIT | OXOID LIMITED | 2022-12-12 |
| 05032384013142 | E. COLI O157 TEST KIT | OXOID LIMITED | 2022-12-08 |
| 05032384034420 | DRYSPOT E. COLI O157 | OXOID LIMITED | 2022-12-04 |
| 05713106544013 | E. coli H4 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544020 | E. coli H5 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544044 | E. coli H6 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544068 | E. coli H7 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544075 | E. coli H8 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544099 | E. coli H9 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544105 | E. coli H10 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544129 | E. coli H11 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544143 | E. coli H12 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544167 | E. coli H14 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05713106544174 | E. coli H15 serum, 5 mL | Ssi Diagnostica A/S | 2021-08-11 |
| 05056080501888 | Wellcolex E.coli O157 | REMEL EUROPE LIMITED | 2021-07-21 |
| 15060392377014 | Mast Assure Antisera | MAST GROUP LIMITED | 2019-05-15 |