FDA.reportPublic FDA data

AFIAS iFOB with AFIAS-50

Primary DI
00880613305255
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
OTC
false
Sterile
false
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
00880613305255PrimaryGS10
08806133005256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880613305255008806133052558806133052550880613305255
08806133005256088061330052568806133005256

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
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00886133010075AFIAS-6/SP AnalyzerFPRR020-4FPRR020-42017-11-06

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