FDA.reportPublic FDA data

Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)

Primary DI
00860013988043
Brand
Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)
Company
ADVANCE DX, INC.
Model
WTSSNG100
Catalog number
WTSSNG100
Device description
Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)
Published
2026-03-03
Public version status
New
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
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
20860013988047PackageGS1100In Commercial Distribution
00860013988043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086001398804720860013988047
00860013988043008600139880438600139880430860013988043

GMDN Terms#

Term, Definition table
TermDefinition
Dried blood spot collection kit IVDA collection of devices and materials intended to be used by a healthcare professional at the point-of-care to collect a dried blood spot (DBS) specimen from capillary or venous blood, for subsequent diagnostic testing or screening. The kit typically includes a lancet and/or hypodermic needle with a syringe, capillary tube(s), a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
847-677-3827nbedrio@adx100.com

Regulatory Flags#

DUNS number
041235184
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013988029500 Single strip cards and 500 foil-LifelineWTS500WTS5002026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)LLS200LLS2002026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)WTSSNG500WTSSNG5002026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontCMT01.8CMT01.82026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsCMT01-DBLCMT01-DBL2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsCMT01-DBL200SQCMT01-DBL200SQ2026-03-03
30860013988020500 Single strip cards and 500 foil-LifelineWTS500WTS5002026-03-03
30860013988037500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)LLS200LLS2002026-03-03
20860013988047Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)WTSSNG100WTSSNG1002026-03-03
30860013988051Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)WTSSNG500WTSSNG5002026-03-03
10860013988064Advance Dx Blood Collection Card: Single strip cards - no lines on the frontCMT01.8CMT01.82026-03-03
10860013988071Advance Dx Blood Collection Card: Double Strip cardsCMT01-DBLCMT01-DBL2026-03-03
00860013988081Advance Dx Blood Collection Card: Triple-Single Strip cardsCMT01-MEGACMT01-MEGA2026-03-03
10860013988095Advance Dx Blood Collection Card: Double-Double Strip cardsCMT01-DBL200SQCMT01-DBL200SQ2026-03-03
00860013988005Advance Dx 100 Blood Collection CardCMT01CMT012025-08-28
00860013988012Blood Specimen Return BagF02F022025-08-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
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