FDA.reportPublic FDA data

Chemical Service Labs, LLC

Primary DI
00860011780502
Brand
Chemical Service Labs, LLC
Company
Protean Resources, LLC.
Model
10101
Device description
Q-Stain: Wright's Stain (1 quart)
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
IAFWright'S Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IAFWright'S StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011780502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011780502008600117805028600117805020860011780502

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 Volume1Quart

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
00860011780519Chemical Service Labs, LLC101042024-03-18
00860011780526Chemical Service Labs, LLC102042024-03-18
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

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Primary DI, Brand, Company table
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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
14719874742796LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2025-02-16
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00860011780519Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
00860011780526Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
04048474058277Histamine ELISA DRG Instruments Gesellschaft mit beschränkter HaftungIAF2023-09-01
00840239058270Histamine ELISA DRG International IncIAF2023-08-26
07290016650617QwikCheck DFI KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.IAF2023-06-08
14719874741591LensHooke Sperm DNA fragmentation test kit (SCD assay)BONRAYBIO CO., LTD.IAF2021-11-18
00630414473499Hematek® Stain Pak - Modified Wright's StainSiemens Healthcare Diagnostics Inc.IAF2020-09-24
00630414503936ADVIA® Autoslide Modified Wright's StainSiemens Healthcare Diagnostics Inc.IAF2020-09-24
00630414503967ADVIA® Autoslide Modified Wright's BufferSiemens Healthcare Diagnostics Inc.IAF2020-09-24
10885380152283CARDINAL HEALTHCardinal Health 200, LLCIAF2018-01-30