FDA.reportPublic FDA data

AFIAS-6/SP Analyzer

Primary DI
00886133010075
Brand
AFIAS-6/SP Analyzer
Company
Boditech Med Inc.
Model
FPRR020-4
Catalog number
FPRR020-4
Device description
AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with
Published
2017-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHOFluorometer, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHOFluorometer, For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170232000AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc.2017-10-13JLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886133010075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886133010075008861330100758861330100750886133010075

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone (TSH) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
732-9180770ageffon@immunostics.com

Regulatory Flags#

DUNS number
689062203
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806133032008ichroma ReaderFPRR001FPRR0012017-10-26
08806133010099ichroma ReaderFPRR001FPRR0012017-10-26
08806679001520ichroma™ CRPi-CHOMRA CRP-25i-CHOMRA CRP-252016-12-20
08806679002718ichroma™ iFOBCFPC-15CFPC-152016-12-20
08806133080849Swab-N-Go Home Test COVID-19 AgCFPT-172023-10-10
08806133010068AFIAS-50FPRR022FPRR0222017-10-19
08806133010136ALFIS-3FPRR028FPRR0282021-12-06
08806133010242NuActorFPRR0322020-06-16
08806133080603NuActor Viral RNA Extraction kitUFPK-1UFPK-12020-06-16
08806133005262AFIAS TSH-SPAFIAS TSH-SPSMFP-572017-10-31
08806133005279AFIAS TSH-VBAFIAS TSH-VBSMFP-582017-11-06
08806133005255AFIAS iFOB with AFIAS-50CFPO-15-1CFPO-15-12017-08-22
08806133010075AFIAS-6/SP AnalyzerFPRR020-4FPRR020-42017-11-06
08806133060353Boditech TSH ControlAFIAS-TSHCLT2018-10-17
08806133070437Boditech TSH CalibratorAFIAS-TSHCAL2018-10-17
08806133010082AFIAS-6/VB AnalyzerFPRR020-5FPRR020-52017-11-06
00880613305255AFIAS iFOB with AFIAS-50CFPO-15-1CFPO-15-12017-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076346010HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
10850076346017HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
05430003908761SEEKER®Lacar MDX TechnologiesKHO2026-01-15
07649996894014abioSCOPEAbionic SAKHO2025-02-18
06974849369380Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
06974849369397Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
08809317541259FREND SystemNanoEnTek, Inc.KHO2024-06-30
08800066300104ASFA® SCANNERMBD CO., Ltd.KHO2023-11-21
06974521002246Superbio Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
06974521006626Bioeasy Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCAROLINA LIQUID CHEMISTRIES CORPORATIONKHO2023-03-10
06974849369298Immunofluorescence ReaderJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2022-12-06
06438147335008AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
06438147335022AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
09120052070521INFINITE 200 PROTecan Austria GmbHKHO2021-06-22
04897078440045ALiA FIA AnalyserSANWA BIOTECH LIMITEDKHO2021-01-27
04897078440052Ariel Fluorescent Immunoassay SystemSANWA BIOTECH LIMITEDKHO2021-01-27
04897078440106Thetis Fluorescent Immunoassay SystemSANWA BIOTECH LIMITEDKHO2021-01-27
30014613336341SofiaQUIDEL CORPORATIONKHO2020-10-21
30014613336648SofiaQUIDEL CORPORATIONKHO2020-10-21
10758750000272VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
10758750001040VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
10758750011308VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
06970136030100NAGuangzhou Labsim Biotech Co., LtdKHO2020-05-20
06970136030216NAGuangzhou Labsim Biotech Co., LtdKHO2020-05-20
08800066300005ASFA SCANNERMBD CO., Ltd.KHO2020-01-29
04560189282896AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360TOSOH CORPORATIONKHO2019-09-02
04560189283992AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900TOSOH CORPORATIONKHO2019-09-02
045601892840059tray SorterTOSOH CORPORATIONKHO2019-09-02
0456018928401219tray SorterTOSOH CORPORATIONKHO2019-09-02