FDA.reportPublic FDA data

Chemical Service Labs, LLC

Primary DI
00860011780526
Brand
Chemical Service Labs, LLC
Company
Protean Resources, LLC.
Model
10204
Device description
Q2-Stain: Modified Wright-Giemsa Stain (gallon)
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HYFGiemsa Stain
IAFWright'S Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYFGiemsa StainHematology1
IAFWright'S StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011780526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011780526008600117805268600117805260860011780526

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Gallon

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in tightly capped container at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2146913484cslab@sbcglobal.net

Regulatory Flags#

DUNS number
078381126
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
00860011780502Chemical Service Labs, LLC101012024-03-18
00860011780519Chemical Service Labs, LLC101042024-03-18
00860011780533Chemical Service Labs, LLC201012024-03-18
00860011780540Chemical Service Labs, LLC302012024-03-18
00860011780557Chemical Service Labs, LLC302042024-03-18
00860011780564Chemical Service Labs, LLC302722024-03-18
00860011780571Chemical Service Labs, LLC401012024-03-18
00860011780588Chemical Service Labs, LLC401042024-03-18
00860011780595Chemical Service Labs, LLC302642024-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414619248Atellica HEMA SMS W-G StainSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414619255Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414619262Atellica HEMA SMS M-W BufferSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414626253Atellica HEMA SMS M-W StainSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414323596Atellica HEMA SMS W-G StainSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414323602Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414323619Atellica HEMA SMS M-W BufferSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414323633Atellica HEMA SMS M-W StainSiemens Healthcare Diagnostics Inc.IAF2026-02-06
14719874743564LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2026-02-06
04015630971404Giemsa Staining KitVentana Medical Systems, Inc.HYF2025-12-15
14719874742796LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2025-02-16
14719874742802LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2025-02-16
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