FDA.reportPublic FDA data

KNOWme™

Primary DI
00816565020366
Brand
KNOWme™
Company
AMEDITECH INC.
Model
88433
Catalog number
88433
Device description
KNOWme™ Dried Blood Spot Collection Card
Published
2023-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00816565020366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816565020366008165650203668165650203660816565020366

GMDN Terms#

Term, Definition table
TermDefinition
Dried blood spot collection card IVDA device intended to be used for dried blood spot collection and preservation, at the point-of-care, for subsequent diagnostic testing or screening. It is typically in the form of paper integrated in a card, on which a whole blood specimen is applied and absorbed onto the collection paper. The card may include a form to capture patient demographic information This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010551716
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
00816565020373KNOWme™88453884532023-05-01
00816565020380KNOWme™88431884312023-05-01
00816565021530eCUP + Drug Screening Device94615946152020-03-17
00816565021547eREADER+ Drug Screening Instrument 551612020-03-05
00816555020390ToxCup Drug Screen CupHT23HT232018-10-08
00816565020007ImmuTest Drugs of Abuse Screen CardIMD-AMPIMD-AMP2016-09-01
00816565020014ImmuTest Drugs of Abuse Screen CardIMD-BARIMD-BAR2016-09-01
00816565020021ImmuTest Drugs of Abuse Screen CardIMD-BZOIMD-BZO2016-09-01
00816565020038ImmuTest Drugs of Abuse Screen CardIMD-COCIMD-COC2016-09-01
00816565020045ImmuTest Drugs of Abuse Screen CardIMD-METIMD-MET2016-09-01
00816565020052ImmuTest Drugs of Abuse Screen CardIMD-OPI300IMD-OPI3002016-09-01
00816565020069ImmuTest Drugs of Abuse Screen CardIMD-THCIMD-THC2016-09-01
00816565020076ImmuTest Drugs of Abuse Screen CardIMD-12MO3IMD-12MO32016-09-01
00816565020083ImmuTest Drugs of Abuse Screen CardIMD-8MTIMD-8MT2016-09-01
00816565020090ImmuTest Drugs of Abuse Screen CardIMD-5BO300IMD-5BO3002016-09-01
00816565020106ImmuTest Drugs of Abuse Screen CardIMDA-3MIMDA-3M2016-09-01
00816565020113ImmuTest Drugs of Abuse Screen CardIMDA-5MIMDA-5M2016-09-01
00816565020120ImmuTest Drugs of Abuse CupIMC-3PIMC-3P2016-09-01
00816565020137ImmuTest Drugs of Abuse CupIMC-5BO3IMC-5BO32016-09-01
00816565020144ImmuTest Drugs of Abuse CupIMC-5MIMC-5M2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
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