FDA.reportPublic FDA data

N/A

Primary DI
00810047420323
Brand
N/A
Company
Scientific Device Laboratory, Inc.
Model
753
Device description
MycoPerm-BLUE [12ml bottle - each]
Published
2023-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KEQMedia, Mounting, Water Soluble

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEQMedia, Mounting, Water SolublePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810047420323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810047420323008100474203238100474203230810047420323

GMDN Terms#

Term, Definition table
TermDefinition
Microscopy mounting medium IVDA substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip, to preserve the specimen and/or the integrity of any dye(s) used for staining, and enhance image quality during microscopic examination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
115927956
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810047422075N/A49452024-08-08
00810047420293N/A7452023-01-30
00810047421061N/A745-12023-01-31
00810047422068N/A345-1002024-07-11
00810047422051N/A5152024-04-17
00810047422044N/A5202024-04-04
00810047422037N/A4912024-02-28
00810047422013N/A495-32024-01-09
00810047422020N/A4852024-01-09
00810047421993N/A5222023-09-21
00810047422006N/A5122023-09-21
00810047421986N/A373-C2023-08-31
00810047421832Scientific Device Laboratory6442023-08-14
00810047421962N/A4602023-06-12
00810047421979N/A4902023-06-12
00810047421863N/A6602023-06-08
00810047421870N/A4552023-06-08
00810047421887N/A3532023-06-08
00810047421894N/A353-A2023-06-08
00810047421900N/A353-B2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10849832001314Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
10849832012211Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
10849832012440Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832001317Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832012214Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832012443Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00673693168052EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693168069EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180733EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180740EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180757EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180764EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180771EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180832EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693218511EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693228695EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235969EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235976EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235990EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693236010EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693236027EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00810047421061N/AScientific Device Laboratory, Inc.KEQ2023-01-31
00613647023778FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEQ2022-12-07
20613647023772FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEQ2022-12-07
10615233078657Tissue-Tek®SAKURA FINETEK U.S.A., INC.KEQ2019-12-15