FDA.report

500 Single strip cards and 500 foil-Lifeline

Primary DI
30860013988020
Company
ADVANCE DX, INC.
Model
WTS500
Catalog number
WTS500
Device description
(5-100 Packs) 500 Single strip cards and 500 foil-Lifeline
Published
2026-03-03
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
true

Related Records

Regulatory Flags

DUNS number
041235184
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
30860013988020PackageGS1500In Commercial Distribution
00860013988029PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
30860013988020PackageGS1500Pack00860013988029In Commercial Distribution
00860013988029PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NNKContainer, Specimen Mailer And Storage, Non-Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
847-677-3826nbedrio@adx100.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
30860013988037500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
20860013988047Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
30860013988051Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
10860013988064Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
10860013988071Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988081Advance Dx Blood Collection Card: Triple-Single Strip cardsADVANCE DX, INC.NNK2026-03-03
10860013988095Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
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