FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisherbrand
DI: 00613647008850
·
Model: 51100
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- Fisherbrand
- Primary DI
- 00613647008850
- Version / Model
- 51100
- Catalog Number
- 23111262
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-11-29
- Public Version
- 1
- Public Version Date
- 2022-12-07
- Public Version Status
- New
- Public Device Record Key
- 2d227938-3f74-4a7b-83a9-c77eda834a0d
Device Description
URINE RGNT STRIP 10SG 100/PK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | Clinical Chemistry | 862.1785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43539 | Urine catalase IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly 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 |
|---|---|---|---|---|---|---|
| Package | 20613647008854 | GS1 | PACK | 1 | In Commercial Distribution | |
| Primary | 00613647008850 | GS1 | ||||
| Package | 30613647008851 | GS1 | case | 24 | In Commercial Distribution | |
| Unit of Use | 10613647008857 | GS1 |
Customer Contacts
- Phone
- +1(724)517-2425
- [email protected]