Iron Reagent Set

Primary DI
00812137011992
Brand
Iron Reagent Set
Company
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model
R1 x 500mL, R2 x 15mL
Catalog number
501-412
Device description
For the quantitative determination of iron in serum. For in vitro diagnostic use only.
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00812137011992PrimaryGS10
00812137012326Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812137011992008121370119928121370119920812137011992
00812137012326008121370123268121370123260812137012326

GMDN Terms#

Term, Definition table
TermDefinition
Iron IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of iron in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004533328quality@cdsolinc.com

Regulatory Flags#

DUNS number
048144997
Device count
2
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812137011879AMYLASE (CNPG3) Reagent Set4 x 120 mL501-4002016-10-12
00812137011848Albumin Reagent500 mL501-3972016-10-12
00812137012005LDH Reagent SetR1 x 500mL, R2 x 125mL501-4132016-10-12
00812137011855Alkaline Phosphatase Reagent SetR1 x 500 mL, R2 x 125 mL501-3982016-10-12
00812137011886AST (SGOT) Reagent SetR1 x 500mL, R2 x 125mL501-4012016-10-12
00812137011961Creatinine Reagent SetR1 x 500mL, R2 x 125mL501-4092016-10-12
00812137012098CRP Reagent SetR1 x 50mL, R2 x 50mL501-4352016-10-12
00812137012142CRP Calibrator Set5 x 2mL502-1542016-10-12
00812137012159CRP Control SetL1 x 3 x 3mL, L2 x 3 x 3mL502-1552016-10-12
00812137012197Multi-Analyte Lipid Control SetL1 x 3mL, L2 x 3mL, L3 x 3mL502-1602016-10-12
00812137012111Chemistry Calibrator Set10 x 5mL, 1 x 50mL502-1512016-10-12
00812137012128Chemistry Control Level I Set10 x 5mL502-1522016-10-12
00812137012135Chemistry Control Level II Set10 x 5mL502-1532016-10-12
00001812701208Triglycerides Reagent500mL501-4172016-10-12
00812137010254CDS-LTX CONTROL6 x 16 mL502-0062016-09-08
00812137010261CDS-LTX PRIMER6 x 16mL502-0072016-09-08
00812137011947Carbon Dioxide Reagent120mL501-4072016-10-12
00812137011916Urea Nitrogen Reagent SetR1 x 500mL, R2 x 125mL501-4042016-10-12
00081213701184Albumin Reagent500 mL501-3972016-10-12
00812137010216Boule Con-Diff Tri-Level6 x 4.5mL501-6052016-09-02

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