daxor.comBlood Volume Analyzer (200)
Daxor Corporation
DAXOR CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003529145 | 3003857949 | DAXOR CORPORATION | 1 | N | 2026-01-01 | 107 Meco Ln Oak Ridge TN US 37830 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B641BVA100SOFTWARE60 | BVA100 - The BVA-100 Software v6.0.4. calculates and reports a blood volume determination based on data retrieved from sampling points taken at timed intervals. The software also determines the patient's ideal blood volume which is derived from the patient's height, weight, and gender. The software compares the computed blood volume against the ideal value to indicate a surplus or deficit in blood volume percentages. | 865-425-0555 | rdodgen@daxor.com |
| B641BVA200 | BVA200CONVKIT - New convenience kit to support a new clinical process and Blood volume analyzer | 865-425-0555 | jadkins@daxor.com |
| B641DAXBVA2 | Daxor BVA - Second Generation Blood Volume Analyzer | 865-425-0555 | lcooper@daxor.com |
| B641MAX1000 | MAX-100 - Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plasma volumes. | 8654250555 | lcooper@daxor.com |
| B641MAX1004 | MAX-100 - Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plas | 865-425-0555 | rdodgen@daxor.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 79183 | 1875641553 | K970419 | DAXOR MAX100 SYRINGE (MAX100) | FMF | 1997-12-22 |
| 79183 | 1974993757 | K964406 | AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER | JWO | 1997-09-25 |
| 79183 | 1957624521 | K251087 | Blood Volume Analyzer (200) | JWO | 2025-08-04 |
| 79183 | 1088662262 | ||||
| 79183 | 1299587990 | ||||
| 79183 | 1929628474 |
Product Codes Associated With Registrations#
PMN#
DAXOR MAX100 SYRINGE (MAX100)
DAXOR CORPORATION
AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
DAXOR CORPORATION
GUDID#
Daxor BVA - Second Generation Blood Volume Analyzer
2025-09-05
MAX-100 - Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plasma volumes.
2018-08-21
MAX-100 - Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for use in determination of total blood and plasma volumes.
2020-09-30
BVA-100 Convenience Kit 9ml - Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes - 9ml Vacutainer
2023-07-24
BVA200CONVKIT - New convenience kit to support a new clinical process and Blood volume analyzer
2023-07-12
BVA-100 Convenience Kits - Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes.
2020-09-30
BVA100 - The BVA-100 Software v6.0.4. calculates and reports a blood volume determination based on data retrieved from sampling points taken at timed intervals. The software also determines the patient's ideal blood volume which is derived from the patient's height, weight, and gender. The software compares the computed blood volume against the ideal value to indicate a surplus or deficit in blood volume percentages.
2018-09-03
MAX-100 - Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plas
2018-08-21
BVA100 - An electro-mechanical carousel instrument that provides movement and placement of blood plasma specimens to ensure the proper counting sequence for a blood volume test.
2018-08-01