FDA.reportPublic FDA data

O&P Collection Vials Total Fix/C&S Kits

Primary DI
M445890240
Brand
O&P Collection Vials Total Fix/C&S Kits
Company
MEDICAL CHEMICAL CORPORATION
Model
890-24
Catalog number
890-24
Device description
Convenience kit containing C&S Vials and Total Fix Vials.
Published
2020-08-31
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
true

Product Codes#

Code, Name table
CodeName
LDXFixative, Metallic Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDXFixative, Metallic ContainingPathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150887000Para-Fix C&S MediumMedical Chemical Corporation2015-05-29JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M445890241PrimaryHIBCC0
M445890240Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fixative, metallicAn agent containing metal employed in the preparation of a histologic or pathologic human specimen for the purpose of maintaining the existing form and structure of all of its constituent elements to be used for general diagnostic applications.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008496861
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
M445890151O&P Collection Vials C&S/Clean Kits890-15890-152020-08-31
M445891051O&P Collection Vials SAF / Clean/ C&S Kits891-05891-052020-08-31
M445891101Unifix / Clean / C&S Kits O&P Collection Vials891-10891-102020-08-31
M445891171Total-Fix / C&S / Clean O&P Collection Kits891-17891-172020-08-31
M44589117ORNGE1Total-Fix / C&S / Clean O&P Collection Kits891-17_ORNGE891-17_ORNGE2020-08-31
M445891201Formalin / C&S / Clean Stool Collection Kits891-20891-202020-08-31
M445892021Total-Fix / Formalin / C&S / Clean O&P Collection Kits892-02892-022020-08-31
M445892031Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M445892030Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M4454505K1Bone Marrow Kit4505K4505K2020-09-09
M445891081O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit891-08891-082020-08-31
M445693A50PACK1SED-CONNECT693A 50 PACK693A 50 PACK2016-09-20
M445693AESEDEA50PACK1SED-CONNECT693A-E SED+EA693A-E SED+EA2016-09-20
M445693AFUNNEL1SED-CONNECT693A-FUNNEL693A-FUNNEL2016-09-20
M445693ASAMPLE1SED-CONNECT693A-Sample693A-Sample2016-09-20
M445694A1MICRO-SED694A694A2016-09-20
M445694AEA1MICRO-SED694A-EA694A-EA2016-09-20
M445694ASAMPLE1MICRO-SED694A-Sample694A-Sample2016-09-20
M445694ATUBEFUNNEL1MICRO-SED694A-TUBE/FUNNEL 1000694A-TUBE/FUNNEL 10002016-09-20
M445695A1PARA-SED695A695A2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838023484REMELREMEL, INC.LDX2023-01-04
00840733103421Para-Pak EcoFix MERIDIAN BIOSCIENCE, INC.LDX2021-10-27
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