FDA.reportPublic FDA data

PREVI® Color Gram RA1 ACETONE SAFRANIN solution

Primary DI
03573026263102
Brand
PREVI® Color Gram RA1 ACETONE SAFRANIN solution
Company
BIOMERIEUX SA
Model
29582
Device description
Gram's method reagent used exclusively on PREVI Color Gram instrument North America
Published
2020-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JTSStains, microbiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTSStains, MicrobiologicHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026263102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026263102035730262631023573026263102

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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