Question 1

What types of medical devices does Affinity Biologicals Inc manufacture?

Accepted Answer

Affinity Biologicals Inc specializes in in vitro diagnostic (IVD) products focused on coagulation testing. Their portfolio includes frozen plasma controls (like VisuCon-F and Visu-Cal F), calibrators, and analyte-specific reagents. These products are designed for laboratory quality assurance and assay development, particularly for coagulation factors such as Factor IX, Factor VIII, and Factor XIII. Examples include enzyme immunoassay (EIA) kits and frozen controls for assessing multiple coagulation factors.

Question 2

Where is Affinity Biologicals Inc based, and what regulatory framework applies to its devices?

Accepted Answer

Affinity Biologicals Inc is headquartered in the United States. Their devices are regulated under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. This means their products must comply with FDA requirements for safety, performance, and labeling before being marketed in the US. The classification of their devices ranges from Class I (generally low-risk) to Class II (moderate-risk), depending on the specific product.

Question 3

Which regulatory registries or databases list Affinity Biologicals Inc’s devices?

Accepted Answer

Affinity Biologicals Inc’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) database. These registries ensure transparency and traceability of medical devices authorized for use in the US, allowing healthcare providers, regulators, and other stakeholders to verify compliance and product details.

Question 4

How are Affinity Biologicals Inc’s coagulation testing devices classified under FDA regulations?

Accepted Answer

Affinity Biologicals Inc’s coagulation testing devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure their safety and effectiveness. The classification is determined based on factors like the device’s intended use, potential harm, and the duration of use.

Device	Model / Reference	Registries	Class	Status
VisuCon-L(TM) Normal Control Plasma	LYNCP01	FDA UDI	Class II	Unknown
VisuCon-F Frozen Normal Control Plasma	FRNCP0125	FDA UDI	Class II	Active
Sheep anti-human Factor XIII Analyte Specific Reagent	SAFXIII-IG-ASR-5	FDA UDI	Class I	Active
VisuLize Factor FIX Antigen Kit	FIX-AG	FDA UDI	Class II	Active
VisuCon-F Frozen Abnormal Control Plasma	FRABP0105	FDA UDI	Class II	Active
VisuCon-F Frozen Coag Screen ABN	FCSAB0181	FDA UDI	Class II	Active
Sheep anti-human Factor XIII Analyte Specific Reagent	SAFXIII-IG-ASR-500	FDA UDI	Class I	Active
VisuCon-F Frozen Abnormal Control Plasma	FRABP0125	FDA UDI	Class II	Active
VisuCon-F Frozen Coag Screen ABN	FCSAB0125	FDA UDI	Class II	Active
VisuCon-F Frozen Coag Screen ABN	FCSAB0481	FDA UDI	Class II	Active
VisuCon-L Coag Screen N Plasma	LSCN01	FDA UDI	Class II	Unknown
VisuCon-F Low Fibrinogen Control Plasma	LFGCP0125	FDA UDI	Class II	Active
VisuCon-F Low Fibrinogen Control Plasma	LFGCP0181	FDA UDI	Class II	Active
Visu-Cal F Frozen Calibrator Plasma	FRSP0105	FDA UDI	Class II	Active
VisuCon-F Frozen Coag Screen N	FCSN0181	FDA UDI	Class II	Active
VisuCal-F Frozen Calibrator Plasma	FRSP0125	FDA UDI	Class II	Active
VisuCon-F Frozen Coag Screen N	FCSN0481	FDA UDI	Class II	Active
VisuCon-F Frozen Coag Screen N	FCSN0125	FDA UDI	Class II	Active
VisuCon-F Low Fibrinogen Control Plasma	LFGCP0105	FDA UDI	Class II	Active
VisuCon-F Frozen Calibrator Plasma	FRNCP0105	FDA UDI	Class II	Active
VisuLize Factor FVIII Antigen Kit	FVIII-AG	FDA UDI	Class II	Active
VisuCon-L Coag Screen ABN2 Plasma	LCSAB201	FDA UDI	Class II	Unknown
VisuCon-L(TM) Abnormal Control Plasma	LYABP01	FDA UDI	Class II	Unknown
VisuCon-L Coag Screen ABN1 Plasma	LCSAB101	FDA UDI	Class II	Unknown
Visulize Factor Ix Antigen Kit	K051054	FDA 510(k)	Class II	Active
Visucal-F Frozen Calibrator Plasma And Visucon-F Frozen Normal And Abnormal Control Plasma	K091284	FDA 510(k)	Class II	Active
Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn	K110432	FDA 510(k)	Class II	Active
VisuCon-F Low Fibrinogen Control Plasma	K150144	FDA 510(k)	Class II	Active
Visulize Factor Viii Antigen Kit, Model Fviii-Ag	K052825	FDA 510(k)	Class II	Active

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