FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hemosure
DI: 00857338006019
·
Model: T1-CK30
·
HEMOSURE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Hemosure
- Primary DI
- 00857338006019
- Version / Model
- T1-CK30
- Catalog Number
- T1-CK30
- Company Name
- HEMOSURE INC.
- Labeler DUNS
- 806777541
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2016-05-09
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 3f304ef1-4e6a-4b33-b60e-bd2521e7d479
- Distribution End Date
- 2016-05-09
Device Description
contains T1-CT30, T1-TB50, T1-CM50. T1-CT30: Hemosure iFOB Test 30 Cassettes Box Set T1-TB50: Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) T1-CM50: Hemosure iFOB 50 Mailers Only Box Set
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| KHE | Reagent, Occult Blood | Hematology | 864.6550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54532 | Faecal occult blood IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857338006019 | GS1 | ||||
| Unit of Use | 00857338006002 | GS1 |