FDA.reportPublic FDA data

Fetal Hemoglobin Kit - 200 test kit

Primary DI
00862066000314
Brand
Fetal Hemoglobin Kit - 200 test kit
Company
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
Model
ST 101-B
Catalog number
ST 101-B
Device description
Kleihauer-Betke Fetal Hemoglobin Test KitIncludes 2 each- 101-10 Red Cell Fixing Solution, 101-20 Citrate Phosphate Buffer, 101-30 Stain Solution
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00862066000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862066000314008620660003148620660003140862066000314

GMDN Terms#

Term, Definition table
TermDefinition
Foeto-maternal haemorrhage/Kleihauer test 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 detection of foetal red blood cells in a maternal clinical specimen, also known as a Kleihauer test, as an indicator of foeto-maternal haemorrhage.

Regulatory Flags#

DUNS number
787125566
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015924209ST 201 Fetal Hemoglobin ControlST 201ST 2012026-05-19
00860015924216ST 201-B Fetal Hemoglobin ControlST 201-BSt 201-B2026-05-19
00860015924223ST 201-C Fetal Hemoglobin ControlST 201-CST 201-C2026-05-19
00862066000307Fetal Hemoglobin Kit - 100 test kitST 101-AST 101-A2026-05-15
00862066000321Fetal Hemoglobin Test Kit - 300 test kitST 101-CST 101-C2026-05-15
00862066000338Red Cell Fixing Solution - 120mL101-10101-102026-05-15
00862066000345Citrate Phosphate Buffer 120 mL101-20101-202026-05-15
00862066000352Hemoglobin Staining Solution101-30101-302026-05-15
00862066000369Red Cell Fixing Solution - 500mL101-10x500101-10x5002026-05-15
00862066000376Citrate Phosphate Buffer 500 mL101-20x500101-20x5002026-05-15
00862066000383Hemoglobin Staining Solution 500 mL101-30x500101-30x5002026-05-15

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
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
00851318008017Simmler, 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