FDA.reportPublic FDA data

Dade® Sickle-Sol Test

Primary DI
00630414976365
Brand
Dade® Sickle-Sol Test
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10459402
Catalog number
10459402
Device description
Qualitative Solubility for sickling hemoglobin
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00630414976365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414976365006304149763656304149763650630414976365

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414976341Dade® Sickle-Sol Test10459400104594002016-09-24
00630414976358Dade® Sickle-Trol Hemoglobin Controls10459401104594012016-09-24
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31

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
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
00816057020034ASI Sickle Cell TestARLINGTON SCIENTIFIC, INC.GHM2016-07-08