FDA.reportPublic FDA data

Ion OneTouch™ Dx Template Supplies

Primary DI
10190302006132
Brand
Ion OneTouch™ Dx Template Supplies
Company
LIFE TECHNOLOGIES CORPORATION
Model
A18933
Published
2017-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PFTReagents for molecular diagnostic test systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFTReagents For Molecular Diagnostic Test SystemsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302006132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030200613210190302006132

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, non-sterileA covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080131636
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
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10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636092025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)A56518A561232025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564412025-02-17
10190302019033TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636132025-02-17
10190302019040TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636082025-02-17
10190302019057TaqPath™ 1-Step Select Master Mix (No ROX)A565192025-02-17
10190302019422Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay KitA572972025-02-17
80190302019438Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferA577402025-02-17
10190302019446Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control9661362025-02-17
10190302006385Oncomine™ Dx Target TestA324412017-06-27
10190302005197Aim -V™ MediumA18398DJ2016-08-01
10190302012041Human CD99 FITC ConjugateMHCD99012018-06-15
10190302012058Human CD99 R-PE ConjugateMHCD99042018-06-15
10190302012065Human CXCR4 (CD184) R-PE ConjugateMHCXCR4042018-06-15
10190302012164Anti-Human HLA-DR (Class II) FITC ConjugateMHLDR012018-06-15
10190302012171Anti-Human HLA-DR (Class II) R-PE ConjugateMHLDR042018-06-15
10190302012188Anti-Human HLA-DR (Class II) APC ConjugateMHLDR052018-06-15
10190302012195Anti-Human HLA-DR (Class II) PE-Texas Red® ConjugateMHLDR172018-06-15

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