Crystal Violet

Primary DI
05060472461421
Brand
Crystal Violet
Company
PRO-LAB, INCORPORATED
Model
PL.8000
Catalog number
PL.8000
Device description
For use in the Gram’s Staining method for the initial differentiation of Gram Positive and Gram Negative bacteria.
Published
2022-12-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ICFCrystal Violet For Histology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ICFCrystal Violet For HistologyHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060472461421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060472461421050604724614215060472461421

GMDN Terms#

Term, Definition table
TermDefinition
Gram stain IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in a Gram stain (also referred to as Brown and Benn or Brown-Hopps stain), that is used for the demonstration and differentiation of bacteria in biological/clinical specimens.

Regulatory Flags#

DUNS number
960418395
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
10628429001223AmnioTest (Nitrazine yellow swab)PL.901PL.9012022-12-26
20628429001220AmnioTest (Nitrazine yellow swab 20 box)PL.901-20PL.901-202022-12-26
30628429001227AmnioTest (Nitrazine yellow swab 100 box)PL.901PL.9012022-12-26
10628429001742Legionella DFA Mounting MediumPL.213PL.2132022-12-25
10628429001049Prolex E. coli O157 Latex Test Reagent Kit (50 tests)PL.070BPL.070B2022-12-26
10628429001056Prolex E. coli O157 Latex Test Reagent Kit (100 tests)PL.071BPL.071B2022-12-26
10628429001100Prolex E. coli O157 Latex Reagent Control NegativePL.076BPL.076B2022-12-26
10628429001124Prolex E. coli Non-O157 Identification KitPL.1070PL.10702022-12-26
10628429001131Prolex E. coli O26 Latex ReagentPL.1071PL.10712022-12-26
10628429001148Prolex E. coli O45 Latex ReagentPL.1072PL.10722022-12-26
10628429001155Prolex E. coli O103 Latex ReagentPL.1073PL.10732022-12-26
10628429001162Prolex E. coli O111 Latex ReagentPL.1074PL.10742022-12-26
10628429001179Prolex E. coli O121 Latex ReagentPL.1075PL.10752022-12-26
10628429001186Prolex E. coli O145 Latex ReagentPL.1076PL.10762022-12-26
10628429001193Prolex E. coli Non-O157 Negative Control Latex ReagentPL.1077PL.10772022-12-26
10628429001209Prolex E. coli O91 Latex ReagentPL.1078PL.10782022-12-26
10628429001216E. coli O157 Antiserum (3ml)PL.6250PL.62502022-12-26
10628429001254AmnioTest Colour CardsPL.902PL.9022022-12-26
10628429000080Prolex Streptococcal Grouping Latex KitPL.030PL.0302022-12-25
10628429000110Prolex Streptococcal Grouping Reagent Latex Suspension Group APL.031PL.0312022-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693090001EprediaRICHARD-ALLAN SCIENTIFIC COMPANYICF2024-09-05
00673693236478EprediaRICHARD-ALLAN SCIENTIFIC COMPANYICF2024-09-05
00850015517112KOVAKOVA INTERNATIONAL, INC.ICF2020-08-12
00855617006606KOVAKOVA INTERNATIONAL, INC.ICF2020-08-12
00855617006057KOVAKOVA INTERNATIONAL, INC.ICF2020-07-30
00850015517020KOVAKOVA INTERNATIONAL, INC.ICF2020-03-09
00850015517037KOVAKOVA INTERNATIONAL, INC.ICF2020-03-09
00850015517044KOVAKOVA INTERNATIONAL, INC.ICF2020-03-09
00850015517051KOVAKOVA INTERNATIONAL, INC.ICF2020-03-09
00850015517068KOVAKOVA INTERNATIONAL, INC.ICF2020-03-09
E3021A852042008Rowley Biochemical Crystal Violet Working SolutionTRANSENE COMPANY, INC.ICF2019-09-16
R36852042008Rowley Biochemical Crystal Violet, CertifiedTRANSENE COMPANY, INC.ICF2019-09-16
SO1020852042008Rowley Biochemical Crystal Violet, 0.1% SolutionTRANSENE COMPANY, INC.ICF2019-09-16
SO1107852042008Rowley Biochemical Crystal Violet, 2% AqueousTRANSENE COMPANY, INC.ICF2019-09-16
SO1127852042008Rowley Biochemical Crystal Violet, 2.5% in 10% AlcoholTRANSENE COMPANY, INC.ICF2019-09-16
SO316852042008Rowley Biochemical Crystal Violet Staining SolutionTRANSENE COMPANY, INC.ICF2019-09-16
SO317852042008Rowley Biochemical Crystal Violet, Hucker'sTRANSENE COMPANY, INC.ICF2019-09-16
SO319852042008Rowley Biochemical Crystal Violet StirlingTRANSENE COMPANY, INC.ICF2019-09-16
SO500852042008Rowley Biochemical Crystal Violet, Lillie'sTRANSENE COMPANY, INC.ICF2019-09-16
SO755A852042008Rowley Biochemical Turk's Crystal VioletTRANSENE COMPANY, INC.ICF2019-09-16