FDA.reportPublic FDA data

Micro SSP™ Gel System - 108 Wells

Primary DI
00814695024452
Brand
Micro SSP™ Gel System - 108 Wells
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
MGS108
Device description
The Micro SSP Gel Box System is a compact gel box for electrophoresis.
Published
2018-06-15
Public version status
Update
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
JJNApparatus, Electrophoresis, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJNApparatus, Electrophoresis, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814695024452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814695024452008146950244528146950244520814695024452

GMDN Terms#

Term, Definition table
TermDefinition
Electrophoresis chamber IVD, manualAn electrically-powered laboratory apparatus intended to be used for the qualitative and/or quantitative in vitro determination of various substances, especially proteins, in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field. The device operates with technician involvement in most procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.822.88241lambda-Techsupport@thermofisher.com

Regulatory Flags#

DUNS number
118289289
Device count
1
Premarket exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06438147368907Migele Gel Electrophoresis UnitWallac OyJJN2018-11-28
M52590140Zip Zone Sponge WicksHELENA LABORATORIES CORPORATIONJJN2017-03-17