FDA.report

Tacha's Bluing Solution 10X

Primary DI
00847627014429
Brand
Tacha's Bluing Solution 10X
Company
BIOCARE MEDICAL LLC
Model
HTBLU-MX
Published
2022-12-07
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

Product Codes

CodeName
HYJHematoxylin

Product Code Classifications

CodeDeviceSpecialtyClass
HYJHematoxylinHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847627014429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627014429008476270144298476270144290847627014429

GMDN Terms

TermDefinition
Differentiation solution IVDA differentiation solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
806617825
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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