FDA.reportPublic FDA data

Mawi DNA Technologies

Primary DI
10850040712060
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
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
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 for dilution of a clinical specimen, 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

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800080220068ACS Combo-B IncubatorBSL Co.,LtdNNL2023-05-11
04038917085403Cool transport containerSarstedt Aktiengesellschaft & Co.KGNNL2022-11-30
00850045030025MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
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
00850040712063Mawi 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
10850040712077Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
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10885380169618CARDINAL HEALTHCardinal Health 200, LLCNNL2019-03-11
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10885380168833CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
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10885380168871CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168888CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20