ASI Sickle Cell Test

Primary DI
00816057020034
Brand
ASI Sickle Cell Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-200100E
Catalog number
NC-200100E
Device description
Detection of the presence of Hgb-S, Export
Published
2016-07-08
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
GHMTest, Sickle Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHMTest, Sickle CellHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020034008160570200348160570200340816057020034

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin S (HbS) 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 qualitative and/or quantitative determination of haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-489-8911info@arlingtonscientific.com

Regulatory Flags#

DUNS number
785966607
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00816057020041ASiManager-ATNC-2400-0BTNC-2400-0BT2016-07-08
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003629901Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629918Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629925Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629932Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00860003629949Sickle-HemeGREAT LAKES DIAGNOSTICS, INC.GHM2021-12-13
00630414976341Dade® Sickle-Sol TestSiemens Healthcare Diagnostics Products GmbHGHM2016-09-24
00630414976365Dade® Sickle-Sol TestSiemens Healthcare Diagnostics Products GmbHGHM2016-09-24
00844509000884Sickle-ChexSTRECK, INC.GHM2016-09-19
00844509000891Sickle-ChexSTRECK, INC.GHM2016-09-19
00844509002024SICKLEDEXSTRECK, INC.GHM2016-09-19
00844509002031SICKLEDEXSTRECK, INC.GHM2016-09-19
00844509002048SICKLEDEXSTRECK, INC.GHM2016-09-19
00845275000740Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHM2016-09-16
00845275000757Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHM2016-09-16
00845275000733Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHM2016-07-19
00816057020003ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08
00816057020010ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08
00816057020027ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08