Home faecal specimen collection kit
- Definition
- A collection of non-sterile devices and materials intended to be used by a layperson to collect and mail a faecal (stool) sample to a clinical laboratory for diagnostic testing or screening purposes (e.g., occult blood, cytology). The kit includes a specimen container(s), preservative, and other items [e.g., collection assistive device(s), labels, and a container with a requisition form for mailing to the laboratory]. This is a single-use device.
- GUDID devices
- 12
- Last updated
- 2020-04-29 04:48:43
Representative GUDID Devices#
| Primary DI | Brand | Company | Model | Published |
|---|---|---|---|---|
| 20809160023751 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 75307 | 2016-08-20 |
| M769FITCHEK331 | FIT-CHEK | Home Access Health Corporation | 33 | 2019-06-22 |
| M769FITCHEK341 | FIT-CHEK | Home Access Health Corporation | 34 | 2018-06-26 |
| 30014613201960 | QuickVue | QUIDEL CORPORATION | iFOB Test | 2016-09-15 |
| 30014613202042 | QuickVue | QUIDEL CORPORATION | iFOB Test | 2016-09-15 |
| 00850093003064 | InSure FIT | ENTERIX INC. | 01 | 2016-09-14 |
| 00850093003187 | InSure FIT | ENTERIX INC. | 01 | 2016-10-03 |
| 00850093003279 | InSure® ONE™ | ENTERIX INC. | 01 | 2018-01-05 |
| 00850093003354 | InSure® ONE™ | ENTERIX INC. | 01 | 2018-01-05 |
| 30850093003317 | InSure® ONE™ | ENTERIX INC. | 01 | 2018-01-05 |
| 00858637005017 | Cologuard Collection Kit | EXACT SCIENCES CORPORATION | 100026 | 2015-02-11 |
| 10304040002565 | Henry Schein | HENRY SCHEIN, INC. | 9004416 | 2016-09-24 |