FDA UDI
In Commercial Distribution
🇺🇸 United States
Alltest BAR300 Rapid Test Panel (Urine)
DI: 06936983113885
·
Model: 1
·
Hangzhou AllTest Biotech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- Alltest BAR300 Rapid Test Panel (Urine)
- Primary DI
- 06936983113885
- Version / Model
- 1
- Catalog Number
- DBA-A114 (300ng)
- Company Name
- Hangzhou AllTest Biotech Co., Ltd.
- Labeler DUNS
- 543254717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2026-04-17
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- d78cd7ef-2531-4c5f-a56b-a66721eeefed
Device Description
25T, for FDA POC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | 862.3150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30517 | Barbiturate IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of barbiturates in a clinical specimen 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 | 86936983113881 | GS1 | ||||
| Primary | 06936983113885 | GS1 |