FDA.reportPublic FDA data

CON-Trate Reagent A

Primary DI
00840733102554
Brand
CON-Trate Reagent A
Company
MERIDIAN BIOSCIENCE, INC.
Model
960001
Catalog number
960001
Device description
Stand Alone Reagent for Use with Meridian's CON-Trate Systems
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IGGFormaldehyde (Formalin, Formol)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IGGFormaldehyde (Formalin, Formol)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733102554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102554008407331025548407331025540840733102554

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-800343-3858MBI-TechService@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840733103193Para-Pak Mayer's Albumin8007008007002026-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733103193Para-Pak Mayer's AlbuminMERIDIAN BIOSCIENCE, INC.IGG2026-07-21
00840733103469Para-Pak SAF (Genova Diagnostics)MERIDIAN BIOSCIENCE, INC.IGG2021-10-27
00840733103377Para-Pak ULTRA 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2021-10-14
00840733102486Para-Pak SAFMERIDIAN BIOSCIENCE, INC.IGG2021-07-06
00840733103360Para-Pak Ultra SAFMERIDIAN BIOSCIENCE, INC.IGG2021-07-06
00840733103391Para-Pak 10% Formalin FixativeMERIDIAN BIOSCIENCE, INC.IGG2021-06-18
00840733101250Para-Pak Zn-PVA / 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102615Para-Pak Zn-PVA / 10% Formalin MERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102806Para-Pak LV-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102813Para-Pak Zn-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102820Para-Pak Zn-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102936Para-Pak LV-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102943Para-Pak SAF/C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102950Para-Pak SAF / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102967Para-Pak LV-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102981Para-Pak Ultra SAF / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102998Para-Pak Zn-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103001Para-Pak SAF/C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103032Para-Pak Modified (Cu) PVA/FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103049Para-Pak Modified (Cu) PVA/FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103063Para-Pak LV-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103070Para-Pak LV-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103087Para-Pak SAF / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103094Para-Pak LV-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103100Para-Pak Zn-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103131Para-Pak ULTRA SAF Fixative / Clean VialMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103148Para-Pak Zn-PVA/Ultra 10% Formalin MERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103179Para-Pak Zn-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103209Para-Pak SAF / Clean / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103216Para-Pak SAF / Clean / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10