FDA.reportPublic FDA data

REMEL

Primary DI
00848838065873
Brand
REMEL
Company
REMEL, INC.
Model
R40140
Catalog number
R40140
Device description
Gram Stain QC Slide PK/10
Published
2023-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LJGQuality Control Slides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838065873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838065873008488380658738488380658730848838065873

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain control IVDA prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065769564
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
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
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
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B502BSB9420CS0Tryptase Control SlidesBIO SB, INC.LJG2025-03-28
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B502BSB0309CS02-Core HHV-8 Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0310CS02-Core Adenovirus Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0333CS02-core Human PIN TMA Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9000CS0A-1-Antichymotrypsin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9001CS0A-1-Antitrypsin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9002CS0ACE2 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9003CS0ACTH Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9004CS0Actin Muscle Specific Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9005CS0Actin Smooth Muscle Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9006CS0Adenovirus Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9007CS0Adipophilin/ADRP Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9008CS0Albumin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9010CS0ALK-1/CD246 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9011CS0Alpha Synuclein Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9012CS0Alpha-Fetoprotein Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9013CS0AMACRacemase/P504S Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9014CS0Amyloid A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9015CS0Amyloid Beta Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9016CS0Androgen Receptor Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9017CS0Annexin A1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9018CS0Annexin VII Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9019CS0Arginase-1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9020CS0ARID1A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9021CS0ATM Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9022CS0ATRX Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9023CS0Aurora B Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9024CS0B7H3/CD276 Control SlidesBIO SB, INC.LJG2025-03-18