FDA.reportPublic FDA data

REMEL

Primary DI
00848838022241
Brand
REMEL
Company
REMEL, INC.
Model
R21051
Catalog number
R21051
Device description
Coagulase Plasma 15ml/VL
Published
2023-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JTLPlasma, Coagulase, Human, Horse And Rabbit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTLPlasma, Coagulase, Human, Horse And RabbitMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838022241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838022241008488380222418488380222410848838022241

GMDN Terms#

Term, Definition table
TermDefinition
Coagulase production microbial reagent IVDA substance or reactant intended to be used in microbial testing to detect the enzyme coagulase, produced by a microorganism isolated from a clinical specimen by culture.

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
00848838022227REMELREMEL, INC.JTL2023-01-03
00848838022258REMELREMEL, INC.JTL2023-01-03
00848838022265REMELREMEL, INC.JTL2023-01-03
05060472467515Rabbit Coagulase Plasma (10x3ml)PRO-LAB, INCORPORATEDJTL2022-12-20
05060472467522Rabbit Coagulase Plasma (1x10ml)PRO-LAB, INCORPORATEDJTL2022-12-20
05060472467539Rabbit Coagulase Plasma (1x20ml)PRO-LAB, INCORPORATEDJTL2022-12-20
05060472467546Rabbit Coagulase Plasma (1x30ml)PRO-LAB, INCORPORATEDJTL2022-12-20
00819398026581Coagulase Cryo™HARDY DIAGNOSTICSJTL2020-08-06
00819398026574Coagulase Cryo™HARDY DIAGNOSTICSJTL2020-08-06
00816576028207CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028221CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028191CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028214CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
30382902406588BD BBL™ Coagulase Plasma, RabbitBECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902406618BD BBL™ Coagulase Plasma, RabbitBECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902408261BD BBL™ Coagulase Plasma, Rabbit with EDTABECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902408278BD BBL™ Coagulase Plasma, Rabbit with EDTABECTON, DICKINSON AND COMPANYJTL2018-05-25