Theriome

GUDID 04779054720665

RDA SPOT, UAB

Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD Dried blood spot collection kit IVD
Primary Device ID04779054720665
NIH Device Record Key73bfba8b-157e-43c2-a963-cf32cd4d8d11
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheriome
Version Model NumberRS24001
Company DUNS681642418
Company NameRDA SPOT, UAB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS104779054720665 [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 Date2024-05-06
Device Publish Date2024-04-26

Devices Manufactured by RDA SPOT, UAB

04779054720665 - Theriome2024-05-06
04779054720665 - Theriome2024-05-06
04779054720108 - RDA Spot2024-01-31

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