FDA.reportPublic FDA data

IntraStain

Primary DI
05700572004387
Brand
IntraStain
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
K2311
Device description
IntraStain
Published
2020-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GGKPRODUCTS, RED-CELL LYSING PRODUCTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGKProducts, Red-Cell Lysing ProductsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572004387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572004387057005720043875700572004387

GMDN Terms#

Term, Definition table
TermDefinition
Specimen stabilization reagent IVDA substance or reactant intended to be used alone or in combination with other IVDs to prevent degradation of sensitive analytes (e.g., hormones, proteins, peptides and/or nucleic acids) in a clinical specimen during transportation, storage or processing. A stabilizer is typically a solvent, antioxidant or an enzyme inhibitor.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544859500dako.dkregulatory@agilent.com

Regulatory Flags#

DUNS number
894671143
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
05700572005971Mono Mo A-Hu Beta-Amyloid Cl 6F/3DM08722020-09-17
05700572033028DakoGA6332026-05-15
05700572033127DakoGA6142026-05-16
05700572033363DakoGA6282026-05-15
05700572034230DakoGA6272026-05-16
05700572005322Mono Mo A-Hu Serotonin Cl 5HT-H209M07582020-09-17
05700574035631Alissa InterpretK5849AA2022-07-11
05700572027799Poly Rb A-Hu Alpha-1-FetoproteinA00082020-09-17
05700572005841Mono Mo A-Hu CD35 Cl Ber-MAC-DRCM08462020-09-17
05700572004912Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572027942Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572516170Mono Mo A-Epstein-Barr Virus, LMP Cls CS. 1-4M08972020-09-17
05700571112182DakoGC1182025-09-02
05700575013812Dako Omnis DI Water Filling AccessoriesGC1212025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareGC1222025-06-25
05700575014031Dako Omnis Waste Tank (NHz)GC1262025-06-25
05700575014048Dako Omnis Waste Tank (Hz)GC1272025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)GC1232025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)GC1242025-06-25
05700572007340Poly Rb A-Hu IgG/HRPP02142016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00664369000899LYSERCELL WDF IISYSMEX CORPORATIONGGK2026-04-24
00630414289991Atellica HEMA HGBSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414290027Atellica HEMA DiffSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414312477Atellica HEMA HGBSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414290003Atellica HEMA BasoSiemens Healthcare Diagnostics Inc.GGK2026-02-06
00630414312491Atellica HEMA DiffSiemens Healthcare Diagnostics Inc.GGK2026-02-06
06903053010641M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06936415908805M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06936415908812M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093116M-5LEO(I) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093123M-5LEO(I) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093130M-5LEO(II) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093147M-5LEO(II) LyseShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093154M-53LH LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
06944904093161M-53LH LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
EBUHBCCRLYR20CAST® Lysing Reagent BasophilBühlmann Laboratories AGGGK2025-03-04
07350040796405Medonic M51-L1 LyseBoule Medical ABGGK2024-10-04
07350040796412Medonic M51-L2 LyseBoule Medical ABGGK2024-10-04
07350040796436Swelab Lumi-L1 LyseBoule Medical ABGGK2024-10-04
07350040796443Swelab Lumi-L2 LyseBoule Medical ABGGK2024-10-04
03610230008157NUCEDIFF (1L)HORIBA ABX SASGGK2024-05-30
07540207107490EasySep™ Red Blood Cell Lysis Buffer, 10X ConcentrateStemcell Technologies Canada IncGGK2024-02-08
15099590744854DxHBeckman Coulter, Inc.GGK2023-12-15
00380740136963AlinityABBOTT LABORATORIESGGK2023-11-16
G507ZAPR01000ZAPR™Incell Corporation, LLCGGK2023-09-06
G507ZAPR04000ZAPR™Incell Corporation, LLCGGK2023-09-06
05999883586167Diatro•Diff-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
05999883586105Diatro•Lyse-DIFFDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
15999883586164Diatro•Diff-5PDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagGGK2023-04-24
04987562422975SULFOLYSERSYSMEX CORPORATIONGGK2022-11-30