Capillary Blood Specimen Collection Supplemental Pack

GUDID G292590

Capillary blood collection kit, professional

Biodesix, Inc.

Capillary blood collection kit, professional
Primary Device IDG292590
NIH Device Record Key94f4e9f7-1fd2-4125-97ed-8dda8ccbe5c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapillary Blood Specimen Collection Supplemental Pack
Version Model Number1
Company DUNS809047215
Company NameBiodesix, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG292590 [Primary]

FDA Product Code

PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-04
Device Publish Date2023-07-27

Devices Manufactured by Biodesix, Inc.

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