FDA.report

REMEL

Primary DI
00848838065712
Brand
REMEL
Company
REMEL, INC.
Model
R40086
Catalog number
R40086
Device description
TB Auramine O (Fluorescent) 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
JTSStains, Microbiologic

Product Code Classifications

CodeDeviceSpecialtyClass
JTSStains, MicrobiologicHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848838065712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838065712008488380657128488380657120848838065712

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.

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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