FDA.reportPublic FDA data

Fetal Hemoglobin

Primary DI
04054839149108
Brand
Fetal Hemoglobin
Company
Sigma-Aldrich, Inc.
Model
285D-1KT
Device description
Fetal Hemoglobin Kit
Published
2016-09-16
Public version status
Update
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
04054839149108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054839149108040548391491084054839149108

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832563121
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04065271997561MIDAS® III-Plus Automated Stainer64000H-942025-01-20
04061831981322PEROXIDASE (MYELOPEROXIDASE)391A-1KT2021-10-21
04061833024386NAPHTHOL AS-MX PHOSPHATE ALKALINE SOLUTION, 0.25%855-20ML2021-10-21
04054839149092Fetal Hemoglobin285C-1KT2016-09-16
04061838789686TRIZMA® CONCENTRATE3913-50ML2022-10-24
04061834129783COPPER NITRATE3912-1VL2022-09-29
04061837283789GILL MODIFIED EA SOLUTION3915-100ML-S2022-09-29
04061838202628PARAROSANILINE SOLUTION1804-15ML2022-04-28
04061838202895PEROXIDASE INDICATOR REAGENT3901-10VL2021-11-17
04061831973013LEUKOCYTE PHOSPHATASE390A-1KT2021-10-21
04061833039984NAPHTHOL AS-BI ALKALINE SOLUTION861-10ML2021-10-21
04061833042328ALKALINE PHOSPHATASE86C-1KT2021-10-21
04061834202226PEROXIDASE INDICATOR REAGENT3901-1VL2021-10-21
04061834202240DIAMINOBENZIDINE3911-1VL2021-10-21
04061838203496FRV-ALKALINE SOLUTION862-10ML2021-10-21
04061838203502FBB-ALKALINE SOLUTION863-10ML2021-10-21
04061838261182ALKALINE PHOSPHATASE86R-1KT2021-10-21
04061826259542CITRATE PHOSPHATE BUFFER CONCENTRATE2851-100ML2021-09-28
04061826259597EOSIN B SOLUTION2853-100ML2021-09-28
04061833032565LEUKOCYTE ALKALINE PHOSPHATASE85L1-1KT2021-09-28

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
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
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