FDA.reportPublic FDA data

AFIAS-50

Primary DI
08806133010068
Brand
AFIAS-50
Company
Boditech Med Inc.
Model
FPRR022
Catalog number
FPRR022
Published
2017-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806133010068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806133010068088061330100688806133010068

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVDAn electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
689062203
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

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
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
00886133010075AFIAS-6/SP AnalyzerFPRR020-4FPRR020-42017-11-06
00880613305255AFIAS iFOB with AFIAS-50CFPO-15-1CFPO-15-12017-08-22