ALFIS-3 FPRR028

GUDID 08806133010136

FLUOROMETER FOR CLINICAL USE

Boditech Med Inc.

Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Primary Device ID08806133010136
NIH Device Record Keyd6fb318f-f8ac-4cd9-905e-f3a300bda365
Commercial Distribution StatusIn Commercial Distribution
Brand NameALFIS-3
Version Model NumberFPRR028
Catalog NumberFPRR028
Company DUNS689062203
Company NameBoditech Med Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806133010136 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-14
Device Publish Date2021-12-06

Devices Manufactured by Boditech Med Inc.

08806133080849 - Swab-N-Go Home Test COVID-19 Ag2023-10-18
08806133010068 - AFIAS-502022-09-16
08806133010099 - ichroma Reader2022-06-10
08806133010136 - ALFIS-32021-12-14FLUOROMETER FOR CLINICAL USE
08806133010136 - ALFIS-32021-12-14 FLUOROMETER FOR CLINICAL USE
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

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