FDA.reportPublic FDA data

500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)

Primary DI
30860013988037
Brand
500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)
Company
ADVANCE DX, INC.
Model
LLS200
Catalog number
LLS200
Device description
Advance Dx 500 Blood Collection Card (5-100 Packs) 500 Double 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

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
30860013988037PackageGS1500In Commercial Distribution
00860013988036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3086001398803730860013988037
00860013988036008600139880368600139880360860013988036

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
847-677-3825nbedrio@adx100.com

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

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
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)WTSSNG100WTSSNG1002026-03-03
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
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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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
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)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