FDA.reportPublic FDA data

COULTER TruColor Giemsa Stain

Primary DI
15099590250751
Brand
COULTER TruColor Giemsa Stain
Company
Beckman Coulter, Inc.
Model
7547201
Catalog number
7547201
Device description
COULTER TruColor Giemsa Stain
Published
2020-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KQCStains, Hematology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQCStains, HematologyHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590250751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959025075115099590250751

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

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Primary DI, Brand, Company table
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14719874742918LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)BONRAYBIO CO., LTD.KQC2025-02-16
008171690247673D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKQC2022-12-29
10664369201385STROMATOLYSER-4DSSYSMEX CORPORATIONKQC2022-11-04
80664369201384STROMATOLYSER-4DSSYSMEX CORPORATIONKQC2022-11-04
15099590204143COULTER TruColor Wright StainBeckman Coulter, Inc.KQC2020-08-31
15099590204150COULTER TruColor Wright-Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590204167COULTER TruColor Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590250706COULTER TruColor Wright StainBeckman Coulter, Inc.KQC2020-08-31
15099590250713COULTER TruColor Wright- Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590250720COULTER TruColor Wright Stain Buffer Beckman Coulter, Inc.KQC2020-08-31
15099590250737COULTER TruColor Wright- Giemsa Stain BufferBeckman Coulter, Inc.KQC2020-08-31
15099590250744COULTER TruColor May Grünwald StainBeckman Coulter, Inc.KQC2020-08-31
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