FDA.reportPublic FDA data

Mawi DNA Technologies

Primary DI
10850040712152
Brand
Mawi DNA Technologies
Company
Mawi Dna Technologies, LLC
Model
ISC-T-1200
Catalog number
ISC-T-1200
Device description
iSWAB Cells Collection Tube 1.0 ml
Published
2022-04-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850040712152PackageGS150In Commercial Distribution
20850040712159PackageGS1500In Commercial Distribution
00850040712155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004071215210850040712152
2085004071215920850040712159
00850040712155008500407121558500407121550850040712155

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
510-256-5186support@mawidna.com

Regulatory Flags#

DUNS number
005460723
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00850040712018Mawi DNA TechnologiesISD-T-1200ISD-T-12002022-04-06
00850040712032Mawi DNA TechnologiesISD-T-250ISD-T-2502022-04-06
00850040712063Mawi DNA TechnologiesISF-T-250ISF-T-2502022-04-06
00850040712070Mawi DNA TechnologiesISF-T-DSCISF-T-DSC2022-04-06
00850040712094Mawi DNA TechnologiesISR2-T-1200ISR2-T-12002022-04-06
00850040712001Mawi Dna TechnologiesiSWAB-DNA-1200iSWAB-DNA-12002022-04-06
00850040712025Mawi DNA TechnologiesISWAB-DNA-250ISWAB-DNA-2502022-04-06
00850040712049Mawi DNA TechnologiesISWAB-DSCISWAB-DSC2022-04-06
00850040712056Mawi DNA TechnologiesISWAB-ID-250ISWAB-ID-2502022-04-06
00850040712087Mawi DNA TechnologiesISWAB-RNA-v2ISWAB-RNA-v22022-04-06
00850040712124Mawi DNA TechnologiesISM-T-1200ISM-T-12002022-04-06
00850040712131Mawi DNA TechnologiesISM-T-ELISM-T-EL2022-04-06
00850040712155Mawi DNA TechnologiesISC-T-1200ISC-T-12002022-04-06
10850040712015Mawi DNA TechnologiesISD-T-1200ISD-T-12002022-04-06
10850040712039Mawi DNA TechnologiesISD-T-250ISD-T-2502022-04-06
10850040712060Mawi DNA TechnologiesISF-T-250ISF-T-2502022-04-06
10850040712077Mawi DNA TechnologiesISF-T-DSCISF-T-DSC2022-04-06
10850040712091Mawi DNA TechnologiesISR2-T-1200ISR2-T-12002022-04-06
00850040712100Mawi DNA TechnologiesiSWAB-MB-1200iSWAB-MB-12002022-04-06
00850040712117Mawi DNA TechnologiesiSWAB-MBF-1200iSWAB-MBF-12002022-04-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
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04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
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