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BION ENTERPRISES, LTD.

Last updated September 17, 2026

Information

Country: US
Address: 455 State St Ste 100, DES PLAINES, IL, 60016
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1419968
DUNS Number: —

Catalogue (106)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Mycoplasma pneumoniae Antigen Substrate, 6 wells, For IFA Test System	MP-1206	FDA UDI	Class I	Unknown
Enterovirus Panel Antigen Control Slide, 4 wells	QEP-6604	FDA UDI	Class I	Active
Parainfluenza 2 Virus Antigen Substrate, 12 wells, For IFA Test System	P2-8112	FDA UDI	Class I	Unknown
Measles IgG Control	MEG-6020	FDA UDI	Class I	Active
Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System	CM-2012	FDA UDI	Class II	Active
Mumps IgG Control	MUG-8020	FDA UDI	Class I	Active
Bp 230 Elisa Test	RG-M7613-D	FDA UDI	Class II	Unknown
Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System	IB-2112	FDA UDI	Class I	Active
ANA Scl-70 Control	SCL-1046	FDA UDI	Class II	Active
RSV IgG Control	RSG-9020	FDA UDI	Class I	Active
Adenovirus Antigen Substrate, 12 wells, For IFA Test System	AD-3112	FDA UDI	Class I	Active
Chlamydia Antigen Contol Slide (Elem. Bodies), 2 wells	QCHE-4502	FDA UDI	Class I	Active
ANA Homogeneous Control	ANP-1040	FDA UDI	Class II	Active
Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System	CB-3312	FDA UDI	Class I	Active
Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System	CB-3306	FDA UDI	Class I	Active
Chlamydia IgG Control	CHM-4130	FDA UDI	Class I	Active
Parainfluenza 1, 2, & 3 Negative Control	PN-8510	FDA UDI	Class I	Unknown
Varicella Zoster IgG Control	VZG-7020	FDA UDI	Class II	Active
Chlamydia Antigen Control Slide, 2 wells	QCH-4102	FDA UDI	Class I	Unknown
ANA ACA Control	ACA-1043	FDA UDI	Class II	Active
Respiratory Virus Panel Antigen Control Slide, 14 wells	QRP-6314	FDA UDI	Class I	Unknown
Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System	AN-1012	FDA UDI	Class II	Active
Parainfluenza Virus Antigen Control Slide, 6 wells	QP-8506	FDA UDI	Class I	Active
Adenovirus IgG Control	ADG-3120	FDA UDI	Class I	Unknown
ANA (HEp-2) Test System, 1800 Tests	AND-1800 I	FDA UDI	Class II	Unknown
Mumps IgM Control	MUM-8030	FDA UDI	Class I	Active
Herpes Simplex Type 1 Virus Antigen Substrate, 12 wells, For IFA Test System	HS1-3012	FDA UDI	Class II	Active
Mumps Antigen Control Slide, 2 wells	QMU-8002	FDA UDI	Class I	Active
EBV IgG Control	EBG-5020	FDA UDI	Class I	Active
Measles IgG Test System, 120 Tests	MEG-120	FDA UDI	Class I	Active
EBV-VCA IgG Test System, 120 Tests	EBG-120	FDA UDI	Class I	Active
Influenza B Negative Control	IBN-2110	FDA UDI	Class I	Active
CMV IgG Test System, 120 Tests	CMG-120	FDA UDI	Class II	Active
Coxsackie B1-B6 Negative Control	CBN-3310	FDA UDI	Class I	Unknown
CMV IgM Control	CMM-2030	FDA UDI	Class II	Active
CMV Negative Control	CMN-2010	FDA UDI	Class II	Active
RSV Negative Control	RSN-9010	FDA UDI	Class I	Active
Dsg 1 & Dsg 3 Elisa Test	RG-M7593-D	FDA UDI	Class II	Unknown
Mycoplasma pneumoniae IgM Control	MPM-1230	FDA UDI	Class I	Active
Mycoplasma pneumoniae Negative Control	MPN-1210	FDA UDI	Class I	Active
HSV-2 IgG Test System, 120 Tests	HS2G-120	FDA UDI	Class II	Active
ANA Nucleolar Control	NUC-1042	FDA UDI	Class II	Active
Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System	AN-1016	FDA UDI	Class II	Unknown
EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System	NA-5112	FDA UDI	Class I	Unknown
Respiratory Syncytial Virus Antigen Substrate, 12 wells, For IFA Test System	RS-9012	FDA UDI	Class I	Active
Measles Negative Control	MEN-6010	FDA UDI	Class I	Active
Mycoplasma pneumoniae Antigen Substrate, 12 wells, For IFA Test System	MP-1212	FDA UDI	Class I	Active
Mumps Negative Control	MUN-8010	FDA UDI	Class I	Active
Influenza A Negative Control	IAN-1110	FDA UDI	Class I	Active
Mumps IgG Test System, 120 Tests	MUG-120	FDA UDI	Class I	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 23, 2013	Z-1477-2013	—	terminated	Affected products have a labeled expiration date of one year too long.
Jan 23, 2013	Z-1478-2013	—	terminated	Affected products have a labeled expiration date of one year too long.
Jan 23, 2013	Z-1479-2013	—	terminated	Affected products have a labeled expiration date of one year too long.