FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-Rad
DI: 00847865001793
·
Model: 25260
·
Bio-RAD Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bio-Rad
- Primary DI
- 00847865001793
- Version / Model
- 25260
- Catalog Number
- 25260
- Company Name
- Bio-RAD Laboratories, Inc.
- Labeler DUNS
- 844766394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-04
- Public Version
- 6
- Public Version Date
- 2021-07-29
- Public Version Status
- Update
- Public Device Record Key
- f4e0e86a-37e3-4de9-b1bc-b89ad2ac1671
Device Description
STOP Stopping Solution 1N 15 x 120 mL
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 |
|---|---|---|---|---|
| MZF | Test, Hiv Detection | Microbiology | 866.3956 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58238 | Sulphuric acid stop solution reagent IVD | A dilute sulphuric acid solution intended to be used to stop enzymatic activity or further development of reactions during the final processing steps of an enzyme immunoassay method, when testing clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847865001793 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 15 x 120 mL |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius