FDA.reportPublic FDA data

Advance Dx Blood Collection Card: Triple-Single Strip cards

Primary DI
00860013988081
Brand
Advance Dx Blood Collection Card: Triple-Single Strip cards
Company
ADVANCE DX, INC.
Model
CMT01-MEGA
Catalog number
CMT01-MEGA
Device description
Advance Dx Blood Collection Card (triple-single strip cards)
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
10860013988088PackageGS125In Commercial Distribution
00860013988081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001398808810860013988088
00860013988081008600139880818600139880810860013988081

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
847-677-3827nbedrio@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
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
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038917581882Salivette®Sarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PPSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055837Screw cap, pastel-greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055998Screw cap, pastel-orangeSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056049Screw cap, pastel-violetSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056148Screw cap, pastel-yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056407Screw cap, pastel-blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057831SafeSeal tube 0.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057879SafeSeal tube 0.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058012SafeSeal tube 0.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058050SafeSeal tube 0.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058135SafeSeal tube 0.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058173SafeSeal tube 0.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058210Micro tube 0.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058296SafeSeal tube 1.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058340SafeSeal tube 1.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058388SafeSeal tube 1.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058425SafeSeal tube 1.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058463SafeSeal tube 1.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058500SafeSeal tube 1.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058548Micro tube 1.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916059354Faeces tube 101x16.5mmSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
00840216129290Quest DiagnosticsAsp Global, LLCNNK2026-07-17
00840216129801LabCorpAsp Global, LLCNNK2026-07-17
G669CNPTLN1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Non-SterileCorramedical Inc.NNK2026-04-07
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