FDA.reportPublic FDA data

Ral Diff-Quik Solution I (1 x 2,5L)

Primary DI
03760177194540
Brand
Ral Diff-Quik Solution I (1 x 2,5L)
Company
R.A.L. DIAGNOSTICS
Model
03760177194540
Published
2018-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
03760177194540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177194540037601771945403760177194540

GMDN Terms#

Term, Definition table
TermDefinition
Romanowsky stain IVD, kitA collection of chemical agents, dyes, and/or other associated materials referred to as a Romanowsky stain, Giemsa, May-Grünwald, Wright, Leishman, Jenner or Field stain, intended to be used for the demonstration of haematopoietic cells, chromosomes, blood parasites, and/or other blood-based pathogens in biological/clinical specimens.

Regulatory Flags#

DUNS number
264611820
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760177194519Ral Diff-Quik EZ-Kit (3 x 100ml)037601771945192018-09-07
03760177194526Ral Diff-Quik Kit (3 x 500ml)037601771945262018-09-07
03760177194533Ral Diff-Quik Fixative Solution (1 x 2,5L)037601771945332018-09-07
03760177194557Ral Diff-Quik Solution II (1 x 2,5L)037601771945572018-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
15099590250751COULTER TruColor Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
00630414976310Diff-Quik™ Solution ISiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414976327Diff-Quik™ Solution IISiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414992617Diff-Quik™ Stain SetSiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414992624Diff-Quik™ FixativeSiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
03760177194519Ral Diff-Quik EZ-Kit (3 x 100ml)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194526Ral Diff-Quik Kit (3 x 500ml)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194533Ral Diff-Quik Fixative Solution (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194557Ral Diff-Quik Solution II (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
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