FDA.reportPublic FDA data

Biochrom EZ Nin Reagent Kit 8L NC

Primary DI
05056336800635
Brand
Biochrom EZ Nin Reagent Kit 8L NC
Company
BIOCHROM LIMITED
Model
80-6003-14
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.
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056336800635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056336800635050563368006355056336800635

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
235280646
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056336800192Bio30+ System Physio Accel80-6000-502023-07-14
05056336800208Bio30+ Physio Accelerated80-6000-512023-07-14
05056336800215Bio30+ Physio Accel W/O A/S80-6000-522023-07-14
05056336800222Bio30+ System Physio HP80-6000-532023-07-14
05056336800239Bio30+ Sys Physio HP EZ Nin80-6000-53EZ2023-07-14
05056336800246Bio30+ Physio High Performance80-6000-542023-07-14
05056336800253Bio30+ Physio W/O A/S HP80-6000-552023-07-14
05056336800260Bio30+ System Physio HR80-6000-562023-07-14
05056336800277Bio30+ Physiological HR80-6000-572023-07-14
05056336800284Bio30+ Physio W/O A/S HR80-6000-582023-07-14
05056336800574Biochrom Ultra Ninhydrin Solution NC80-6003-082023-07-14
05056336800598Biochrom Ultra Ninhydrin Kit 2L NC80-6003-102023-07-14
05056336800604Biochrom Ultra Ninhydrin Kit 8L NC80-6003-112023-07-14
05056336800611Biochrom EZ Nin Reagent Kit 2L NC80-6003-122023-07-14
05056336800628Biochrom EZ Nin Reagent Kit 4L NC80-6003-132023-07-14
05056336801052Biochrom EZ Nin reagent (2L) NC80-6003-192023-07-14

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