Product code MHJ
- Device name
- Cryptosporidium 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 |
|---|---|---|---|
| K171078 | TRI-COMBO PARASITE SCREEN | Techlab, Inc. | 2017-07-10 |
| K121565 | UNI-GOLD CRYPTOSPORIDIUM | Trinity Biotech | 2013-02-08 |
| K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK | Techlab, Inc. | 2005-11-17 |
| K052932 | CRYPTOSPORIDIUM II | Techlab, Inc. | 2005-11-04 |
| K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | Remel, Inc. | 2003-11-14 |
| K031059 | IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 | Ivd Research, Inc. | 2003-07-10 |
| K982764 | PREMIER CRYPTOSPORIDIUM | Meridian Diagnostics, Inc. | 1998-12-03 |
| K982709 | MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY | Alexon - Trend, Inc. | 1998-09-03 |
| K980354 | CRYPTOSPORIDIUM TEST | Techlab, Inc. | 1998-05-18 |
| K955852 | CRYPTO-CEL IF TEST | Techlab, Inc. | 1996-08-05 |
| K955755 | TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS | Trend Scientific, Inc. | 1996-07-11 |
| K955345 | LMD CRYPTOSPORIDIUM ANTIGEN DETECTION | Lmd Laboratories | 1996-06-07 |
| K936191 | PROSPECT CRYPTOSPORIDIUM RAPID ASSAY | Alexon Biomedical, Inc. | 1994-11-17 |
| K912242 | PROSPECT(TM/CRYPTOSPORIDIUM | Alexon, Inc. | 1992-03-23 |
| K905598 | CRYPTOSPORIDIUM ANTIGEN DETECTION | Lmd Laboratories | 1991-09-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048474060591 | Giardia/Cryptosporidium Ag (stool) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474034677 | Cryptosporidium Antigen (stool) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239034670 | Cryptosporidium Antigen (stool) ELISA | DRG International Inc | 2023-08-24 |
| 00083059070637 | Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2020-07-01 |
| 00857031002547 | TRI-COMBO PARASITE SCREEN | TECHLAB, INC. | 2019-05-31 |
| 00857031002400 | TRI-COMBO PARASITE SCREEN | TECHLAB, INC. | 2017-10-05 |
| 08305900070637 | Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2016-12-08 |
| 00848838026898 | NA | REMEL, INC. | 2016-09-24 |
| 00848838026904 | NA | REMEL, INC. | 2016-09-24 |
| 00848838026935 | NA | OXOID LIMITED | 2016-09-24 |
| 00893038002180 | Triage® | Alere San Diego, Inc. | 2016-09-21 |
| M445MCCCGDFA750 | Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| 05391516746342 | TrinityBiotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 05391516746359 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 00857031002035 | CRYPTOSPORIDIUM II | TECHLAB, INC. | 2016-08-23 |
| 00857031002127 | GIARDIA/CRYPTOSPORIDIUM CHEK | TECHLAB, INC. | 2016-08-23 |
| 00857031002240 | GIARDIA/CRYPTOSPORIDIUM CHEK | TECHLAB, INC. | 2016-08-23 |
| 00857031002301 | CRYPTOSPORIDIUM II | TECHLAB, INC. | 2016-08-23 |