FDA.reportPublic FDA data

Simmler, Inc.

Primary DI
00851318008017
Brand
Simmler, Inc.
Company
SIMMLER INC
Model
S0412-100
Device description
Fetal Cell Stain Kit 100 Test
Published
2017-10-19
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
GHQStain, Fetal Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHQStain, Fetal HemoglobinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851318008017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851318008017008513180080178513180080170851318008017

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin F (HbF) 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 F (HbF), also known as foetal haemoglobin, in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6363768347customerservice@simmler.com

Regulatory Flags#

DUNS number
056955776
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851318008000Simmler, Inc.S0412-002017-10-19
00851318008024Simmler, Inc.S0412A-1002017-10-19
00851318008031Simmler, Inc.S0411-062017-10-19
00851318008048Simmler, Inc.S0412C2017-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00862066000307Fetal Hemoglobin Kit - 100 test kitSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00862066000314Fetal Hemoglobin Kit - 200 test kitSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00862066000321Fetal Hemoglobin Test Kit - 300 test kitSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00862066000338Red Cell Fixing Solution - 120mLSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00862066000345Citrate Phosphate Buffer 120 mLSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00862066000352Hemoglobin Staining SolutionSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00862066000369Red Cell Fixing Solution - 500mLSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00862066000376Citrate Phosphate Buffer 500 mLSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00862066000383Hemoglobin Staining Solution 500 mLSURE-TECH DIAGNOSTIC ASSOCIATES, INC.GHQ2026-05-15
00851318008000Simmler, Inc.SIMMLER INCGHQ2017-10-19
00851318008024Simmler, Inc.SIMMLER INCGHQ2017-10-19
00851318008031Simmler, Inc.SIMMLER INCGHQ2017-10-19
00851318008048Simmler, Inc.SIMMLER INCGHQ2017-10-19
04054839149092Fetal HemoglobinSigma-Aldrich, Inc.GHQ2016-09-16
04054839149108Fetal HemoglobinSigma-Aldrich, Inc.GHQ2016-09-16
10190302005333Human Fetal Hemoglobin Test KitLIFE TECHNOLOGIES CORPORATIONGHQ2016-08-01
10190302005340Human Fetal Hemoglobin Test KitLIFE TECHNOLOGIES CORPORATIONGHQ2016-08-01
10190302005579Human Fetal Hemoglobin FITC ConjugateLIFE TECHNOLOGIES CORPORATIONGHQ2016-08-01
10190302005586Human Fetal Hemoglobin FITC ConjugateLIFE TECHNOLOGIES CORPORATIONGHQ2016-08-01
10190302005593Anti-Human Fetal Hemoglobin R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONGHQ2016-08-01
10190302005609Anti-Human Fetal Hemoglobin R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONGHQ2016-08-01