FDA.reportPublic FDA data

Rowley Biochemical Gelatin

Primary DI
E5852042008
Brand
Rowley Biochemical Gelatin
Company
TRANSENE COMPANY, INC.
Model
1
Catalog number
E-5
Device description
Gelatin
Published
2019-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IEXGelatin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IEXGelatinPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E5852042008PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mucopolysaccharide fraction IVD, kit, liquid chromatographyA collection of reagents and other associated materials intended to be used for the quantitative measurement of mucopolysaccharide fractions in a clinical specimen, using a liquid chromatography method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
044815983
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
SO471852042008Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution1SO-4712019-09-16
SO920852042008Rowley Biochemical Congo Red, 10% Aqueous12022-12-16
SO959852042008Rowley Biochemical Congo Red, 0.1% Aqueous1SO-9592019-09-16
E3021A852042008Rowley Biochemical Crystal Violet Working Solution1E-302-1A2019-09-16
E3031852042008Rowley Biochemical Sirius Red F3BA Solution1E-303-12019-09-16
E3101852042008Rowley Biochemical Carmine Stock1E-310-12019-09-16
F3646852042008Rowley Biochemical Biebrich Scarlet Solution, 1%1F-364-42019-09-16
F3833852042008Rowley Biochemical Gomori's Chromium Hematoxylin1F-383-32019-09-16
R18852042008Rowley Biochemical Biebrich Scarlet, Certified1R-182019-09-16
R34852042008Rowley Biochemical Congo Red, Certified1R-342019-09-16
R36852042008Rowley Biochemical Crystal Violet, Certified1R-362019-09-16
R3852042008Alizarin Red, Certified1R-32019-09-16
R84852042008Rowley Biochemical Nuclear Fast Red1R-842019-09-16
SO1020852042008Rowley Biochemical Crystal Violet, 0.1% Solution1SO-10202019-09-16
SO1076852042008Rowley Biochemical Puchtler's Modification of Congo Red1SO-10762019-09-16
SO1077852042008Rowley Biochemical Sirius Red Solution1SO-10772019-09-16
SO1107852042008Rowley Biochemical Crystal Violet, 2% Aqueous1SO-11072019-09-16
SO1127852042008Rowley Biochemical Crystal Violet, 2.5% in 10% Alcohol1SO-11272019-09-16
SO1256852042008Rowley Biochemical Working Congo Red1SO-12562019-09-16
SO130852042008Rowley Biochemical Nuclear Fast Red Solution1SO-1302019-09-16