FDA.reportPublic FDA data

Para-Pak EcoFix

Primary DI
00840733103421
Brand
Para-Pak EcoFix
Company
MERIDIAN BIOSCIENCE, INC.
Model
9014-01
Catalog number
9014-01
Device description
Para-Pak EcoFix is a convenient one-vial system for the routine collection, transportation, preservation, and examination of stool specimens for the intestinal parasites. Both concentration and permanent stain may be performed from EcoFix preserved specimens. The fixative affords and excellent means of minimizing the adverse effects of delay in specimen transport.
Published
2021-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDXFixative, Metallic Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDXFixative, Metallic ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733103421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733103421008407331034218407331034210840733103421

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen container IVD, transport buffer/mediumA covered receptacle containing transport buffer solution or microbiological medium (e.g., Carey-Blair transport medium) intended to be used for the collection, preservation, and transport of a faecal specimen for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. 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
1-800-343-3858MBI-TechService@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
00840733102585Hemo-De8013008013002020-12-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838023484REMELREMEL, INC.LDX2023-01-04
00840733103346Para-Pak Ultra EcoFix MERIDIAN BIOSCIENCE, INC.LDX2021-07-06
00840733103407Para-Pak SVTMERIDIAN BIOSCIENCE, INC.LDX2021-07-06
00840733103353Para-Pak Zn-PVAMERIDIAN BIOSCIENCE, INC.LDX2021-06-18
00840733103414Para-Pak Ultra SVTMERIDIAN BIOSCIENCE, INC.LDX2021-06-18
00840733101250Para-Pak Zn-PVA / 10% FormalinMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733102479Para-Pak Zn-PVAMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733102615Para-Pak Zn-PVA / 10% Formalin MERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733102622Para-Pak EcoFix / CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733102769Para-Pak Zn-PVAMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733102813Para-Pak Zn-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733102820Para-Pak Zn-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733102998Para-Pak Zn-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103056Para-Pak EcoFix/CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103100Para-Pak Zn-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103117Para-Pak EcoFix / C&S / CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103124Para-Pak EcoFix / C&S / CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103148Para-Pak Zn-PVA/Ultra 10% Formalin MERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103155Para-Pak Ultra EcoFix/CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103162Para-Pak Ultra EcoFix/Clean MERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103179Para-Pak Zn-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103223Para-Pak Ultra EcoFix / C&S / CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733103230Para-Pak Ultra EcoFix / C&S / CleanMERIDIAN BIOSCIENCE, INC.LDX2020-12-10
00840733102042Para-Pak EcoFixMERIDIAN BIOSCIENCE, INC.LDX2020-12-09
00840733102066Para-Pak MERIDIAN BIOSCIENCE, INC.LDX2020-12-09
00840733102073Para-Pak SVTMERIDIAN BIOSCIENCE, INC.LDX2020-12-09
00840733102400Para-Pak EcoFixMERIDIAN BIOSCIENCE, INC.LDX2020-12-09
00840733102493Para-Pak Ultra EcoFixMERIDIAN BIOSCIENCE, INC.LDX2020-12-09
00840733102509Para-Pak Ultra SVT MERIDIAN BIOSCIENCE, INC.LDX2020-12-09
00840733102677Para-Pak EcoFix in BiobagsMERIDIAN BIOSCIENCE, INC.LDX2020-12-09