FDA.reportPublic FDA data

MIDAS® III-Plus Automated Stainer

Primary DI
04065271997561
Brand
MIDAS® III-Plus Automated Stainer
Company
Sigma-Aldrich, Inc.
Model
64000H-94
Published
2025-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPASlide Stainer, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04065271997561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065271997561040652719975614065271997561

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide maker/stainer IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used to prepare, transfer or fix blood, tissue or other clinical specimens onto microscope examination slides, and then stain the slides using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832563121
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

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Primary DI, Brand, Company table
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07613336140956BenchMark GXVentana Medical Systems, Inc.KPA2025-12-15
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05700575014048Dako Omnis Waste Tank (Hz)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
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