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
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Regulatory Flags#

DUNS number
235280646
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056336801090BIO 30+ LI ACC W COOL A/S & PH80-6004-042026-09-25
05056336801106BIO 30+ LI HP W COOL A/S & PH80-6004-052026-09-25
05056336801113BIO 30+ LI HR W COOL A/S & PH80-6004-062026-09-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906718167HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718174HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718181HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718198HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718204HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718211HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718235HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718242HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718259HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718266HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718273HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718280HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718310HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718327HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718334HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718341HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718358Not ApplicableBecton, Dickinson And CompanyMVU2026-09-24
00382906718365HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718372HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718389HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718396HorizonBecton, Dickinson And CompanyMVU2026-09-24
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