FDA.report

REMEL

Primary DI
00848838065781
Brand
REMEL
Company
REMEL, INC.
Model
R40106
Catalog number
R40106
Device description
TB Decolorizer (Acid Alcohol)3% BTL/250ml
Published
2023-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PPMGeneral Purpose Reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848838065781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838065781008488380657818488380657810848838065781

GMDN Terms

TermDefinition
Acid-alcohol solution IVDAn acid-alcohol solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

Sterilization Methods

Method

Regulatory Flags

DUNS number
065769564
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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