FDA.report

Trichrome Blue Stain

Primary DI
00840733102417
Brand
Trichrome Blue Stain
Company
MERIDIAN BIOSCIENCE, INC.
Model
400501
Catalog number
400501
Device description
Trichrome Blue is a stain which provides excellent differentiation of microsporidium spores in fresh and preserved stool, urine sediment, nasopharyngeal aspirates and other bodily fluids.
Published
2020-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JTSStains, Microbiologic

Product Code Classifications

CodeDeviceSpecialtyClass
JTSStains, MicrobiologicHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840733102417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102417008407331024178407331024170840733102417

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
513-271-3700info@meridianbioscience.com

Regulatory Flags

DUNS number
092815364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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