FDA UDI
In Commercial Distribution
🇺🇸 United States
Ricca Chemical Company LLC
DI: 00192024049827
·
Model: 5260-16
·
Ricca Chemical Company, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ricca Chemical Company LLC
- Primary DI
- 00192024049827
- Version / Model
- 5260-16
- Catalog Number
- 5260
- Company Name
- Ricca Chemical Company, LLC
- Labeler DUNS
- 020335667
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 1
- Public Version Date
- 2023-07-13
- Public Version Status
- New
- Public Device Record Key
- bf9446d2-7740-4a92-aa64-591cb87d5b8a
Device Description
Nessler Reagent, Folin-Wu Modified for Determination of Non-Protein Nitrogen (NPN)
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JMY | CITRULLINE, ARSENATE, NESSLER (COLORIMETRY), ORNITHINE CARBAMYL TRANSFERASE | Clinical Chemistry | 862.1535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34483 | Ornithine carbamoyltransferase IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of ornithine carbamoyltransferase in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192024049827 | GS1 |
Customer Contacts
- Phone
- +1(817)461-5601
- [email protected]