| Primary Device ID | 08806133005279 |
| NIH Device Record Key | 0d915ff1-b84f-4d5e-9cc6-eafd04ee2dba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AFIAS TSH-VB |
| Version Model Number | AFIAS TSH-VB |
| Catalog Number | SMFP-58 |
| Company DUNS | 689062203 |
| Company Name | Boditech Med Inc. |
| Device Count | 24 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com | |
| Phone | 732-9180770 |
| ageffon@immunostics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806133005279 [Primary] |
| GS1 | 18806133005276 [Unit of Use] |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-17 |
| Device Publish Date | 2017-11-06 |
| 08806133080849 - Swab-N-Go Home Test COVID-19 Ag | 2023-10-18 |
| 08806133010068 - AFIAS-50 | 2022-09-16 |
| 08806133010099 - ichroma Reader | 2022-06-10 |
| 08806133010136 - ALFIS-3 | 2021-12-14 FLUOROMETER FOR CLINICAL USE |
| 08806133005262 - AFIAS TSH-SP | 2020-06-17 AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic |
| 08806133005279 - AFIAS TSH-VB | 2020-06-17AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid indiciduals. |
| 08806133005279 - AFIAS TSH-VB | 2020-06-17 AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro d |
| 08806679001520 - ichroma™ CRP | 2020-06-17 |
| 08806679002718 - ichroma™ iFOB | 2020-06-17 |