FDA.reportPublic FDA data

Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION)

Primary DI
00657498001158
Brand
Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION)
Company
STANBIO LABORATORY, L.P.
Model
0325-006
Catalog number
0325-006
Device description
For the Quantitative Colorimetric Determination of Hemoglobin in Whole Blood.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJZCyanomethemoglobin Reagent And Standard Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJZCyanomethemoglobin Reagent And Standard SolutionHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498001158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498001158006574980011586574980011580657498001158

GMDN Terms#

Term, Definition table
TermDefinition
Cyanomethemoglobin kitA test system consisting of one or multiple reagents and other items intended to measure the concentration of cyanomethemoglobin in a biological sample. Measurements are used to determine the concentration of haemoglobin for the detection of anaemia.

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
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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