FDA UDI
In Commercial Distribution
🇺🇸 United States
hema-screen SPECIFIC GOLD
DI: 10722355002900
·
Model: HSGDCAS-25
·
Immunostics Company, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- hema-screen SPECIFIC GOLD
- Primary DI
- 10722355002900
- Version / Model
- HSGDCAS-25
- Catalog Number
- HSGDCAS-25
- Company Name
- Immunostics Company, Inc
- Labeler DUNS
- 119214195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-04-16
- Public Version
- 1
- Public Version Date
- 2025-04-24
- Public Version Status
- New
- Public Device Record Key
- dc4eea95-8b1a-4956-95b2-5acd805e1247
Device Description
The hema-screen Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 80722355002909 | GS1 | ||||
| Primary | 10722355002900 | GS1 |
Customer Contacts
- Phone
- 7329180770
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius