FDA.reportPublic FDA data

LEUKOCYTE PHOSPHATASE

Primary DI
04061831973013
Brand
LEUKOCYTE PHOSPHATASE
Company
Sigma-Aldrich, Inc.
Model
390A-1KT
Published
2021-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GIATest, Leukocyte Peroxidase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIATest, Leukocyte PeroxidaseHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04061831973013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061831973013040618319730134061831973013

GMDN Terms#

Term, Definition table
TermDefinition
Differentiation solution IVDA differentiation solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.

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
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
04054839149108Fetal Hemoglobin285D-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
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
04061838789686TRIZMA® CONCENTRATESigma-Aldrich, Inc.GIA2022-10-24
04061834129783COPPER NITRATESigma-Aldrich, Inc.GIA2022-09-29
04061837283789GILL MODIFIED EA SOLUTIONSigma-Aldrich, Inc.GIA2022-09-29
04061838202895PEROXIDASE INDICATOR REAGENTSigma-Aldrich, Inc.GIA2021-11-17
04061831981322PEROXIDASE (MYELOPEROXIDASE)Sigma-Aldrich, Inc.GIA2021-10-21
04061834202226PEROXIDASE INDICATOR REAGENTSigma-Aldrich, Inc.GIA2021-10-21
04061834202240DIAMINOBENZIDINESigma-Aldrich, Inc.GIA2021-10-21