FDA UDI
In Commercial Distribution
🇺🇸 United States
Biochrom EZ Nin Reagent Kit 8L NC
DI: 05056336800635
·
Model: 80-6003-14
·
BIOCHROM LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Biochrom EZ Nin Reagent Kit 8L NC
- Primary DI
- 05056336800635
- Version / Model
- 80-6003-14
- Company Name
- BIOCHROM LIMITED
- Labeler DUNS
- 235280646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-14
- Public Version
- 1
- Public Version Date
- 2023-07-24
- Public Version Status
- New
- Public Device Record Key
- de438d3c-4bdb-47f9-8842-10f3fa607115
Device Description
Reagent is designed to give a color reaction with any primary or secondary amino acid, in addition to some amines. This product is an Analyte Specific Reagent. Analytical and performance characteristics are not established. The Analyte Specific Reagent is intended to be used as a component of an in-house developed test used exclusively by laboratories. Product sold as 4 x 2L.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64705 | Assay development analyte-specific reagent IVD | An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056336800635 | GS1 |