AFIAS TSH-SP SMFP-57

GUDID 08806133005262

AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in serum, sodium-heparinized plasma, or EDTA Plasma samples.

Boditech Med Inc.

Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent Thyroid stimulating hormone (TSH) IVD, reagent
Primary Device ID08806133005262
NIH Device Record Keya5a3a267-8af6-4877-81f0-40ada1813865
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFIAS TSH-SP
Version Model NumberAFIAS TSH-SP
Catalog NumberSMFP-57
Company DUNS689062203
Company NameBoditech Med Inc.
Device Count24
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS108806133005262 [Primary]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]
GS118806133005269 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use
KHOFluorometer, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-17
Device Publish Date2017-10-31

Devices Manufactured by Boditech Med Inc.

08806133005262 - AFIAS TSH-SP2020-06-17AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in serum, sodium-heparinized plasma, or EDTA Plasma samples.
08806133005262 - AFIAS TSH-SP2020-06-17 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-VB2020-06-17 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™ CRP2020-06-17
08806679002718 - ichroma™ iFOB2020-06-17
08806133005255 - AFIAS iFOB with AFIAS-502019-12-13
08806133010075 - AFIAS-6/SP Analyzer2019-12-13 AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) site
00886133010075 - AFIAS-6/SP Analyzer2018-07-06 AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) site
00880613305255 - AFIAS iFOB with AFIAS-502018-03-29

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