FDA.reportPublic FDA data

AFIAS iFOB with AFIAS-50

Primary DI
08806133005255
Brand
AFIAS iFOB with AFIAS-50
Company
Boditech Med Inc.
Model
CFPO-15-1
Catalog number
CFPO-15-1
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOXAutomated Occult Blood Analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOXAutomated Occult Blood AnalyzerHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806133005255PrimaryGS10
18806133005252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806133005255088061330052558806133005255
1880613300525218806133005252

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood 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 qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
689062203
Device count
25
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816917027838OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-04-03
00816917027814OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-03-18
00816917027784OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-03-13
00816917027791OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-03-13
00816917027807OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-03-13
00816917027760OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-27
00816917027777OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-27
00816917027753OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-13
00816917027708OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027715OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027722OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027739OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027746OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027692OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-16
00816917027685OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-12
00816917027630OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027647OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027654OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027661OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027678OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027623OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-21
00816917027517OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027524OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027531OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027548OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027555OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027562OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027579OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027586OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027593OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07