FDA.reportPublic FDA data

Unsaturated Iron-Binding Capacity

Primary DI
04015630928088
Brand
Unsaturated Iron-Binding Capacity
Company
Roche Diagnostics GmbH
Model
5975808190
Catalog number
5975808190
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JIYPhotometric method, iron (non-heme)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIYPhotometric Method, Iron (Non-Heme)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630928088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630928088040156309280884015630928088

GMDN Terms#

Term, Definition table
TermDefinition
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of unsaturated iron binding capacity (UIBC) of a clinical specimen, using a spectrophotometry method. UIBC is typically determined by measuring the available capacity of the transport protein transferrin to bind free iron.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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