FDA.reportPublic FDA data

Hemo-De

Primary DI
00840733102585
Brand
Hemo-De
Company
MERIDIAN BIOSCIENCE, INC.
Model
801300
Catalog number
801300
Device description
Clearing agent for parasitology, Use as a xylene replacement in Trichrome Stain procedure, Ethyl acetate replacement in concentration procedures, Bulk reagent used in EcoStain kit.
Published
2020-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HYWStain, Trichrome, Mallory'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYWStain, Trichrome, Mallory'SHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733102585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102585008407331025858407331025850840733102585

GMDN Terms#

Term, Definition table
TermDefinition
Faecal parasite isolation kit IVDA collection of reagents and other associated materials (e.g., filters, containers) intended to be used for the isolation and concentration of intestinal parasites [e.g., helminth eggs and larvae, protozoan trophozoites and cysts] from a faecal specimen, using one or a combination of techniques (e.g., centrifugation, filtration, organic solvent or surfactant treatment), for further in vitro diagnostic investigation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
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
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09
00840733102493Para-Pak Ultra EcoFix9813129813122020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693089869EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-05
00673693169028EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-05
00673693169042EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-05
00673693089845EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-04
00673693169035EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-04
00840733103452Trichrome StainMERIDIAN BIOSCIENCE, INC.HYW2021-07-07
00840733102547EcoStainMERIDIAN BIOSCIENCE, INC.HYW2020-12-09
00840733101960Para-Pak TRICHROME STAINMERIDIAN BIOSCIENCE, INC.HYW2020-10-06
00840733102431Trichrome StainMERIDIAN BIOSCIENCE, INC.HYW2020-09-21
00840733102660Modified Hemo-DeMERIDIAN BIOSCIENCE, INC.HYW2020-09-21
00845275005011Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsHYW2016-09-16