FDA UDI
In Commercial Distribution
🇺🇸 United States
Unfilled Easy 2 Stool Extraction Device
DI: B24280EZDEV21000
·
Model: 80-EXDEV2-100
·
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Unfilled Easy 2 Stool Extraction Device
- Primary DI
- B24280EZDEV21000
- Version / Model
- 80-EXDEV2-100
- Catalog Number
- 80-EXDEV2-100
- Company Name
- AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
- Labeler DUNS
- 784143778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-02
- Public Version
- 1
- Public Version Date
- 2026-02-10
- Public Version Status
- New
- Public Device Record Key
- e2d5da1a-d6a4-45e0-92ba-af2edb2fd510
Device Description
The unfilled Easy 2 Stool Extraction Device is intended for the preparation of human stool samples in conjunction with a designated buffer for analysis in compatible test kits. It is for in vitro diagnostic use in the United States and Canada.
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
- Yes
- 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 |
|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62669 | Clinical specimen extraction buffer IVD | A buffered solution intended to be used for the processing and preparation of a clinical specimen, for subsequent in vitro diagnostic testing, by extraction of specific target analytes present in the clinical specimen (e.g., proteins, antigens). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B24280EZDEV21000 | HIBCC |
Customer Contacts
- Phone
- 800.592.5726
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 28 Degrees Celsius