FDA.reportPublic FDA data

Advance Dx Blood Collection Card: Double-Double Strip cards

Primary DI
00860013988098
Brand
Advance Dx Blood Collection Card: Double-Double Strip cards
Company
ADVANCE DX, INC.
Model
CMT01-DBL200SQ
Catalog number
CMT01-DBL200SQ
Device description
Advance Dx Blood Collection Card (double-double 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
10860013988095PackageGS125In Commercial Distribution
00860013988098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001398809510860013988095
00860013988098008600139880988600139880980860013988098

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00827989007772Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007796Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
B24280EZEX21000Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2025-10-30
00810185250004TherapakTherapak LLCNNK2025-08-11
00810185250042TherapakTherapak LLCNNK2025-08-11
00810185250202TherapakTherapak LLCNNK2025-08-11
00810185250349TherapakTherapak LLCNNK2025-08-11
00810185250608TherapakTherapak LLCNNK2025-08-11
00810185250646TherapakTherapak LLCNNK2025-08-11
00810185250561TherapakTherapak LLCNNK2025-08-04
00810185250622TherapakTherapak LLCNNK2025-08-04
00840216128729QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
04038917086318Urine receptacle 500mlSarstedt Aktiengesellschaft & Co.KGNNK2025-05-19
00860013899264Paternity Test Kit 50Ditek Consulting, LLCNNK2025-05-06
00860013899288Paternity Test Kit 25Ditek Consulting, LLCNNK2025-05-06
00860011770268Covid 19 Testing KitDitek Consulting, LLCNNK2025-05-01
00613647027059FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027066FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027073FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027080FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027097FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30