FDA.reportPublic FDA data

invitrogen

Primary DI
10190302059015
Brand
invitrogen
Company
LIFE TECHNOLOGIES, CORPORATION
Model
A32998
Published
2016-07-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OOIreal time Nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103302000STEMPRO MSC SFMLife Technologies Corporation2011-02-18NDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302059015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030205901510190302059015

GMDN Terms#

Term, Definition table
TermDefinition
Medical device-decontamination agentA non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078441189
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302000185Anode Buffer Container, 3500 Dx Series43939252016-08-01
10190302000239Cathode Buffer Container, 3500 Dx Series44082582016-08-01
10190302000154POP-6™ (960) Performance Optimized Polymer, 3500 Dx Series43937112016-08-01
10190302000178POP-6™ (384) Performance Optimized Polymer, 3500 Dx Series43937162016-08-01
10190302000246Conditioning Reagent, 3500 Dx Series44095432016-08-01
10190302000192Hi-Di™ Formamide, 3500 Dx Series44043072016-08-01
10190302000147POP-7 (384) Performance Optimized Polymer, 3500Dx43937092020-04-15
10190302000161POP-7 (960) Performance Optimized Polymer, 3500Dx43937132020-04-15

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