DAXOR CORPORATION

Address:107 Meco Lane,Oak Ridge,TN,37830,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Syringe, Piston (FMF) (2) Device, Blood Volume Measuring (JWO) (1) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (1) System, Blood Collection, Vacuum-Assisted, Manual (KST) (1)

Premarket Exempt

No Yes

Clear

BVA100 - B641BVA100SOFTWARE60 Catalog Number :

Device Description : The BVA-100 Software v6.0.4. calculates and reports a blood volume determination

Device Class : 2

Duns Number: 790888833

Premarket Exempt : No

Product Code : JWO

Prescription Use : No

Device Count : 1

BVA-100 Convenience Kits - B641CONVKIT1000 Catalog Number :

Device Description : Collection of medical components used to withdraw blood samples for use in deter

Device Class : 1

Duns Number: 790888833

Premarket Exempt : Yes

Product Code : KST

Prescription Use : Yes

Device Count : 1

MAX-100 - B641MAX1000 Catalog Number :

Device Description : Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-13

Device Class :

Duns Number: 790888833

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 1

MAX-100 - B641MAX10055 Catalog Number :

Device Description : Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for

Device Class : 2

Duns Number: 790888833

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : Yes

Device Count : 1

BVA100 - B641SC25MK20 Catalog Number :

Device Description : An electro-mechanical carousel instrument that provides movement and placement o

Device Class : 1

Duns Number: 790888833

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

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