FDA.reportPublic FDA data

SpeciMAX Dx Stabilized Saliva Collection Kit

Primary DI
10190302016766
Brand
SpeciMAX Dx Stabilized Saliva Collection Kit
Company
LIFE TECHNOLOGIES CORPORATION
Model
A51023
Published
2022-02-03
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

Product Codes#

Code, Name table
CodeName
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190302016766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019030201676610190302016766

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790376607
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
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564402025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636122025-02-17
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30860013988051Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
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