Identity
- Trade Name
- Biochrom EZ Nin Reagent Kit 4L NC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- 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 2 x 2L. FDA UDI
- Model / Reference
- 80-6003-13 FDA UDI
- 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 2 x 2L. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056336800628 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assay development analyte-specific reagent IVD
Biochrom EZ Nin Reagent Kit 4L NC by Biochrom Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biochrom Limited
Sources (1)
- FDA UDI ad74abf3-2d25-447e-8573-78af90e278ed 33 fields · synced Jun 8, 2026