FDA UDI
In Commercial Distribution
🇺🇸 United States
hema-screen SPECIFIC GOLD
DI: 10722355003068
·
Model: HSGDENV-20
·
Immunostics Company, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- hema-screen SPECIFIC GOLD
- Primary DI
- 10722355003068
- Version / Model
- HSGDENV-20
- Catalog Number
- HSGDENV-20
- Company Name
- Immunostics Company, Inc
- Labeler DUNS
- 119214195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- 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
- a5468e93-e35d-49c0-982f-702500d5b61c
Device Description
Home fecal specimen collection kit for hema-screen SPECIFIC GOLD IFOB products.
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 |
|---|---|---|---|---|
| 61352 | Faecal specimen collection kit IVD, home-use | A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80722355003067 | GS1 | ||||
| Primary | 10722355003068 | GS1 |
Customer Contacts
- Phone
- 7329180770
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius