FDA UDI
In Commercial Distribution
🇺🇸 United States
HB CTRL 1 Kit
DI: 00858637005680
·
Model: 100327
·
EXACT SCIENCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HB CTRL 1 Kit
- Primary DI
- 00858637005680
- Version / Model
- 100327
- Company Name
- EXACT SCIENCES CORPORATION
- Labeler DUNS
- 150908853
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-27
- Public Version
- 1
- Public Version Date
- 2021-09-06
- Public Version Status
- New
- Public Device Record Key
- 068a261f-fa2b-4f5f-8d39-d9ac8daa55a3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54533 | Faecal occult blood IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858637005680 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130017 | 000 |