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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 2 of 3

Device	Model / Reference	Registries	Class	Status
ANA RNP Control	RNP-1044	FDA UDI	Class II	Active
Echovirus Negative Control	ECN-4410	FDA UDI	Class I	Unknown
EBV-VCA IgM Test System, 120 Tests	EBM-120	FDA UDI	Class I	Active
Influenza A IgG Control	IAG-1120	FDA UDI	Class I	Active
EBNA Positive Control	NA-5140	FDA UDI	Class I	Unknown
Herpes Simplex IgM Control	HSM-3530	FDA UDI	Class II	Active
Echovirus Screen Virus Antigen Substrate, 12 wells, For IFA Test System	EC-4412	FDA UDI	Class I	Active
Respiratory Syncytial Virus Antigen Control Slide, 2 wells	QRS-9002	FDA UDI	Class I	Active
Influenza A & B Virus Antigen Control Slide, 4 wells	QAB-1504	FDA UDI	Class I	Active
Measles (Rubeola) Antigen Control Slide, 2 wells	QME-6002	FDA UDI	Class I	Active
Herpes Simplex Virus Antigen Control Slide, 4 wells	QHS-3504	FDA UDI	Class I	Active
Cytomegalovirus Antigen Control Slide, 2 wells	QCM-2002	FDA UDI	Class I	Active
Borrelia IgG Control	BBG-6120	FDA UDI	Class II	Active
Varicella Zoster Virus Antigen Control Slide, 2 wells	QVZ-7002	FDA UDI	Class I	Active
Influenza B IgG Control	IBG-2120	FDA UDI	Class I	Active
EBV Negative Control	EBN-5010	FDA UDI	Class I	Active
ANA SSA Control	SSA-1045	FDA UDI	Class II	Active
Borrelia Negative Control	BBN-6110	FDA UDI	Class II	Active
Mumps IgG Test System, 60 Tests	MUG-60	FDA UDI	Class I	Unknown
Mycoplasma pneumoniae IgG Control	MPG-1220	FDA UDI	Class I	Active
ANA (HEp-2) Test System, 120 Tests	ANK-120	FDA UDI	Class II	Active
Parainfluenza 1 Virus Antigen Substrate, 12 wells, For IFA Test System	P1-7112	FDA UDI	Class I	Unknown
Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System	IA-1112	FDA UDI	Class I	Active
Adenovirus Negative Control	ADN-3110	FDA UDI	Class I	Unknown
Chlamydia Antigen Substrate, 12 wells, For IFA Test System	CH-4112	FDA UDI	Class I	Active
Coxsackie B1-B6 IgG Control	CBG-3320	FDA UDI	Class I	Unknown
ANA (HEp-2) Test System, 60 Tests	ANK-60	FDA UDI	Class II	Active
Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System	EB-5012	FDA UDI	Class I	Active
Measles IgM Test System, 120 Tests	MEM-120	FDA UDI	Class I	Active
ANA Negative Control	ANN-1010	FDA UDI	Class II	Active
ANA SSB Control	SSB-1047	FDA UDI	Class II	Active
Varicella Zoster IgM Control	VZM-7030	FDA UDI	Class II	Active
Measles IgM Control	MEM-6030	FDA UDI	Class I	Active
Herpes Simplex Negative Control	HSN-3510	FDA UDI	Class II	Active
Mumps Virus Antigen Substrate, 12 wells, For IFA Test System	MU-8012	FDA UDI	Class I	Active
Varicella Zoster Negative Control	VZN-7010	FDA UDI	Class II	Active
Chlamydia IgG Control	CHG-4120	FDA UDI	Class I	Active
Parainfluenza 1, 2, & 3 IgG Control	PG-8520	FDA UDI	Class I	Unknown
Mumps Virus Antigen Substrate, 6 wells, For IFA Test System	MU-8006	FDA UDI	Class I	Unknown
HSV-1 IgG Test System, 120 Tests	HS1G-120	FDA UDI	Class II	Active
Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System	AN-1006	FDA UDI	Class II	Active
Measles (Rubeola) Virus Antigen Substrate, 12 wells, For IFA Test System	ME-6012	FDA UDI	Class I	Active
ANA (HEp-2) Test System, 300 Tests	AND-300 I	FDA UDI	Class II	Active
CMV IgG Control	CMG-2020	FDA UDI	Class II	Active
Adenovirus Antigen Control Slide, 2 wells	QAD-3102	FDA UDI	Class I	Active
Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System	HS2-4012	FDA UDI	Class II	Active
EBV IgM Control	EBM-5030	FDA UDI	Class I	Active
Borrelia IgM Control	BBM-6130	FDA UDI	Class II	Active
Parainfluenza 3 Virus Antigen Substrate, 12 wells, For IFA Test System	P3-9112	FDA UDI	Class I	Unknown
Bp 180 Elisa Test	RG-M7612-D	FDA UDI	Class II	Unknown

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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.