FDA.reportPublic FDA data

Revvity GRNK1 Card

Primary DI
00812589021105
Brand
Revvity GRNK1 Card
Company
Revvity, Inc.
Model
Dried Blood Spot Collection Card
Catalog number
GRNK1
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00812589021105PrimaryGS10
00812589020016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812589021105008125890211058125890211050812589021105
00812589020016008125890200168125890200160812589020016

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.

Regulatory Flags#

DUNS number
968495627
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812589020948PerkinElmer GRNK1 CardDried Blood Spot Collection CardGRNK12022-09-23
00812589020955PerkinElmer GRNK1 CardDried Blood Spot Collection CardGRNK12022-09-23
20812589020010Revvity 226Newborn Screening Card2016-08-29
30812589020017Revvity 226Newborn Screening Card2016-08-29
40812589020014Revvity 226Newborn Screening Card2016-08-29
50812589020011Revvity 226Newborn Screening Card2016-08-29
60812589020018Revvity 226Newborn Screening Card2016-08-29
00812589021112Revvity GRNK1 CardDried Blood Spot Collection CardGRNK12023-08-17

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
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
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