FDA UDI
In Commercial Distribution
🇺🇸 United States
hema-screen Triple 335
DI: 10722355002146
·
Model: HSTR-335CS
·
IMMUNOSTICS COMPANY, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
335
Basic Information
- Brand Name
- hema-screen Triple 335
- Primary DI
- 10722355002146
- Version / Model
- HSTR-335CS
- Company Name
- IMMUNOSTICS COMPANY, INC
- Labeler DUNS
- 119214195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 335
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- cafca951-ff8e-4319-b8cf-31439dc913e3
Device Description
Fecal Occult Blood IVD, Guaiac
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 |
|---|---|---|---|---|
| 54531 | Faecal occult blood IVD, kit, rapid colorimetric, 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) within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly 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 |
|---|---|---|---|---|---|---|
| Package | 20722355002143 | GS1 | Case of 3 | 3 | In Commercial Distribution | |
| Primary | 10722355002146 | GS1 | ||||
| Unit of Use | 80722355002145 | GS1 |
Customer Contacts
- Phone
- +1(732)918-0770
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat and light. Do not refrigerate.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius