FDA.report

REMEL

Primary DI
00848838031311
Brand
REMEL
Company
REMEL, INC.
Model
R40121
Catalog number
R40121
Device description
Methanol (absolute) 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
00848838031311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838031311008488380313118488380313110848838031311

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00842558116402BactiSwab Dry PK/100R7231352025-06-19
00848838066665Amies Clear Gel,Single Swab PK/500R7230002025-06-18
00848838066672Amies Clear Gel,Single Swab PK/50R7230052025-06-18
00848838066689Amies Clear Gel,Dual Swab PK/500R7230102025-06-18
00848838066696Amies Clear Gel,Dual Swab PK/50R7230152025-06-18
00848838066702Amies Clear Gel,Wire Shaft Swab PK/100R7230202025-06-18
00848838066719Amies Clear Gel,Wire Shaft PK/50R7230252025-06-18
00848838066757Amies Charcoal Gel,Single Swab PK/50R7230452025-06-18
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00673693089180EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693089197EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693201957EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693168984EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-09
00673693168991EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-07
00673693169080EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-07
30382902125250BD BBL™ Gram Crystal VioletBECTON, DICKINSON AND COMPANYJTS2023-09-19
00810047421986N/AScientific Device Laboratory, Inc.JTS2023-08-31
00810047421863N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047421887N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047421894N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047421900N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047421948N/AScientific Device Laboratory, Inc.JTS2023-06-08
00848838031328REMELREMEL, INC.JTS2023-01-04
00848838031335REMELREMEL, INC.JTS2023-01-04
00848838031342REMELREMEL, INC.JTS2023-01-04
00848838031359REMELREMEL, INC.JTS2023-01-04
00848838031489REMELREMEL, INC.JTS2023-01-04
00848838031502REMELREMEL, INC.JTS2023-01-04
00848838064203REMELREMEL, INC.JTS2023-01-04
00848838065576REMELREMEL, INC.JTS2023-01-04
00848838065583REMELREMEL, INC.JTS2023-01-04
00848838065644REMELREMEL, INC.JTS2023-01-04
00848838065651REMELREMEL, INC.JTS2023-01-04
00848838065668REMELREMEL, INC.JTS2023-01-04
00848838065699REMELREMEL, INC.JTS2023-01-04
00848838065712REMELREMEL, INC.JTS2023-01-04
00848838065729REMELREMEL, INC.JTS2023-01-04
00848838065736REMELREMEL, INC.JTS2023-01-04
00848838065750REMELREMEL, INC.JTS2023-01-04