Question 1

What types of medical devices does Axis-Shield Diagnostics Limited manufacture?

Accepted Answer

Axis-Shield Diagnostics Limited specializes in in vitro diagnostic (IVD) products, including reagents, controls, kits, and calibrators. Their portfolio covers assays for homocysteine, B-type natriuretic peptide (BNP) and NT-proBNP, vitamin B12, and cyclic citrullinated peptide antibodies (anti-CCP). These devices are designed for clinical chemistry and immunology testing, often used in automated laboratory platforms like chemiluminescent and enzyme immunoassays.

Question 2

Where is Axis-Shield Diagnostics Limited based?

Accepted Answer

Axis-Shield Diagnostics Limited is headquartered in the United States. The company’s operations and regulatory compliance are aligned with US-based standards and requirements.

Question 3

Which regulatory registries or databases list Axis-Shield Diagnostics Limited’s devices?

Accepted Answer

Axis-Shield Diagnostics Limited’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US regulatory requirements for in vitro diagnostics.

Question 4

How are Axis-Shield Diagnostics Limited’s devices classified under FDA regulations?

Accepted Answer

Axis-Shield Diagnostics Limited’s devices fall into two primary FDA classification categories: Class I and Class II. 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 safety and effectiveness. The classification depends on the device’s intended use and potential health impact.

Question 5

What is the purpose of the in vitro diagnostic products made by Axis-Shield Diagnostics Limited?

Accepted Answer

Axis-Shield Diagnostics Limited’s IVD products are developed to support clinical laboratory testing for conditions like cardiovascular health (e.g., BNP/NT-proBNP), nutritional deficiencies (e.g., vitamin B12), and autoimmune diseases (e.g., anti-CCP for rheumatoid arthritis). These assays provide quantitative or qualitative results to aid in diagnosis, monitoring, or treatment decisions in a clinical setting.

Device	Model / Reference	Registries	Class	Status
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit	FHRWR100	FDA UDI	Class II	Active
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit	FHRWR1000	FDA UDI	N/A	Unknown
Alere NT-proBNP for Alinity Control Kit	04S7911	FDA UDI	Class I	Active
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit	FHRWR200	FDA UDI	N/A	Active
Axis-Shield Homocysteine Controls	FHCY200	FDA UDI	Class I	Active
Axis-Shield Active-B12 (Holotranscobalamin) EIA	FMABT100	FDA UDI	Class II	Active
3-Reagent Homocysteine Assay for SYNCHRON UniCel	FHYB100/B08175	FDA UDI	Class II	Active
Alere NT-proBNP for Alinity Reagent Kit (200 Tests)	04S7921	FDA UDI	Class II	Active
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent	FHBC100/B08176	FDA UDI	Class II	Active
Alere NT-proBNP for Alinity Calibrator Kit	04S7902	FDA UDI	Class II	Active
Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA	FCCP600	FDA UDI	Class II	Unknown
Axis® Homocysteine EIA	FHCY100	FDA UDI	Class I	Unknown
Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIA	FCCP600	FDA UDI	Class II	Active
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)	K160757	FDA 510(k)	Class II	Active
Abbott Axsym B-Type Natriuretic Peptide (bnp) Microparticle Enzyme Immunoassay (meia) Test	K033606	FDA 510(k)	Class II	Active
Diastat Total Anti-Cardiolipin, Model Fcar 100t	K020156	FDA 510(k)	Class II	Active
Diastat Anti-B2 Glycoprotein 1 Igm, Model Fbgp 100m	K031177	FDA 510(k)	Class II	Active
Axsym Anti-Ccp Reagent, Standard Calibrator And Control Kits, Models 3l91-20, 3l91-01 And 3l91-10	K063347	FDA 510(k)	Class II	Active
Architect Active B-12 (holotranscobalamin)	K112443	FDA 510(k)	Class II	Active
Axis-Shield Acvtive-B12	K121946	FDA 510(k)	Class II	Active
Abbott Axsym Anti-Thyroid-Peroxidase, Models5f57 Comprising Standards/Calibrators	K020348	FDA 510(k)	Class II	Active
Axis-Shield 3-Reagent Homocysteine Assay For Synchron	K112790	FDA 510(k)	Class II	Active
Diastat Anti-Thyroid Peroxidase Elisa Model #300	K020687	FDA 510(k)	Class II	Active
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay	K172133	FDA 510(k)	Class II	Active
Architect Anti-Ccp (100 Test), Architect Anti-Ccp (500 Test), Models 1p65-25, 1p65-35	K083868	FDA 510(k)	Class II	Active
Axis-Shield Liquid Stable (ls) 2-Part Homocysteine Reagent, Model Fhrk100	K083222	FDA 510(k)	Class II	Active
Diastat Anti Cyclic Citrullinated Peptide (anti-Ccp) Elisa	K023285	FDA 510(k)	Class II	Active
Abbott Axsym Anti-Thyroglobulin, Models 5f5b Comprising Standard/Calibrators	K020349	FDA 510(k)	Class II	Active
Axis-Shield Anti-Ccp	K110296	FDA 510(k)	Class II	Active
Alere NT-proBNP for Alinity i	K253539	FDA 510(k)	Class II	Active
Alere NT-proBNP for Alinity i Reagent Kit	K241176	FDA 510(k)	Class II	Active
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.	K153551	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Architect Homocysteine Reagents, Calibrators And Controls	K073640	FDA 510(k)	Class II	Active
Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (meia)	K041866	FDA 510(k)	Class I	Active
ARCHITECT Active-B12 (Holotranscobalamin)	K233541	FDA 510(k)	Class II	Active
ADVIA Centaur Erythropoietin (EPO) assay	K183088	FDA 510(k)	Class II	Active
Architect Hba1c, Architect Hba1c, And Architect Hba1c	K121842	FDA 510(k)	Class II	Active
Diastat Anti Cyclic Citrullinated Peptide Elisa, Model Fccp 200	K021516	FDA 510(k)	Class II	Active
Axsym Holo Tc Reagent Kit, Model 3l83-20; Standard Calibrator Kit, Model 3l83-01; Control Kit, Model 3l83-10	K062467	FDA 510(k)	Class II	Active
Axsym Hba1c Reagents, Axsym Hba1c Calibrators, Axsym Hba1c Controls	K072686	FDA 510(k)	Class II	Active
ADVIA Centaur Calcitonin (CALCT) assay	K182012	FDA 510(k)	Class II	Active

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