FDA.reportPublic FDA data

REMEL

Primary DI
00848838024375
Brand
REMEL
Company
REMEL, INC.
Model
R21921
Catalog number
R21921
Device description
SAF Fixative (15ml Vial) PK/120
Published
2022-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IGBSolution, Formalin-Sodium Acetate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IGBSolution, Formalin-Sodium AcetatePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838024375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838024375008488380243758488380243750848838024375

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen container IVD, fixativeA covered plastic receptacle containing a fixative solution [e.g., sodium acetate, acetic acid and/or formaldehyde (SAF), Schaudinn’s, polyvinyl alcohol (PVA) or acid alcohol] intended to be used for the collection, and preservation and/or transport, of a faecal specimen for analysis and/or other investigation [e.g., evaluation for the presence of intestinal parasites and/or their eggs (ova)]. This is a single-use device.

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
00848838024214REMELREMEL, INC.IGB2022-12-23
00848838024221REMELREMEL, INC.IGB2022-12-23
00816085022260Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-11
00816085022154Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
00816085022550Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
00816085022666Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
00816085022833Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
M445891051O&P Collection Vials SAF / Clean/ C&S KitsMEDICAL CHEMICAL CORPORATIONIGB2020-08-31
M445891081O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection KitMEDICAL CHEMICAL CORPORATIONIGB2020-08-31
M445891050O&P Collection Vials SAF / Clean/ C&S KitsMEDICAL CHEMICAL CORPORATIONIGB2020-08-31