FDA.reportPublic FDA data

Mawi DNA Technologies

Primary DI
00850040712063
Brand
Mawi DNA Technologies
Company
Mawi Dna Technologies, LLC
Model
ISF-T-250
Catalog number
ISF-T-250
Device description
iSWAB-ID Human DNA Collection Tube 400 ul
Published
2022-04-06
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
NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850040712060PackageGS150In Commercial Distribution
20850040712067PackageGS1500In Commercial Distribution
00850040712063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004071206010850040712060
2085004071206720850040712067
00850040712063008500407120638500407120630850040712063

GMDN Terms#

Term, Definition table
TermDefinition
Molecular grade buffered sample diluent IVDA molecular grade buffered solution intended to be used as a diluent for a clinical specimen, reagent and/or other substances used prior to, or during an assay using a nucleic acid technique (NAT).

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
005460723
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

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
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
10850040712121Mawi DNA TechnologiesISM-T-1200ISM-T-12002022-04-06

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Primary DI, Brand, Company table
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00850045030032MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850045030049MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850045030056MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850040712018Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712032Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712070Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712001Mawi Dna TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712015Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712025Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712039Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712049Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712056Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712060Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712077Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
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