FDA.reportPublic FDA data

MYCOFAST US

Primary DI
03661540100031
Brand
MYCOFAST US
Company
ELITECH MICROBIO
Model
00050
Catalog number
00050
Device description
MYCOFAST US has been designed for the detection, enumeration and identification of Ureaplasma urealyticum (U.u.) and Mycoplasma hominis (M.h.) in various clinical sspecimens.
Published
2018-12-10
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
JTODiscs, Strips And Reagents, Microorganism Differentiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540100031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540100031036615401000313661540100031

GMDN Terms#

Term, Definition table
TermDefinition
Mycoplasma species broth culture medium IVDA supplemented broth culture medium intended to be used to enhance the growth of Mycoplasma species in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
299579792
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540100505MYCOPLASMA CONTROL00900009002019-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810144911267RediporAnalytiChem USA, Inc.JTO2023-09-21
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00848838004131REMELREMEL, INC.JTO2023-01-03
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00848838022616REMELREMEL, INC.JTO2023-01-03
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00848838022678REMELREMEL, INC.JTO2023-01-03
00848838022715REMELREMEL, INC.JTO2023-01-03
00848838022746REMELREMEL, INC.JTO2023-01-03
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00848838022821REMELREMEL, INC.JTO2023-01-03