FDA.reportPublic FDA data

Bio30+ Physio W/O A/S HR

Primary DI
05056336800284
Brand
Bio30+ Physio W/O A/S HR
Company
BIOCHROM LIMITED
Model
80-6000-58
Device description
Ion exchange chromatography analyzer sold with lithium high resolution column.
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
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056336800284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056336800284050563368002845056336800284

GMDN Terms#

Term, Definition table
TermDefinition
Amino acid analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of individual amino acids in a protein sample obtained from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
235280646
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing 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
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
05056336800635Biochrom EZ Nin Reagent Kit 8L NC80-6003-142023-07-14
05056336801052Biochrom EZ Nin reagent (2L) NC80-6003-192023-07-14

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