Question 1

What types of medical devices does Streck manufacture?

Accepted Answer

Streck specializes in in vitro diagnostics (IVDs) primarily for hematology and blood collection. Their portfolio includes controls and calibrators for full blood count assays, reticulocyte counts, erythrocyte sedimentation rate (ESR), and glucose/hemoglobin measurements. They also produce evacuated blood collection tubes (with additives like sodium citrate and potassium EDTA) and specialized kits for viral extraction and blood sample preservation. These devices support laboratory testing and blood handling workflows.

Question 2

Where is Streck based, and does that affect the regulatory classification of their devices?

Accepted Answer

Streck is headquartered in the United States. The regulatory classification of their devices varies by jurisdiction: in the EU, most are classified as Class A or Class B, while in the US, they fall under Class I or Class II. Classification depends on factors like risk level, intended use, and procedural involvement, not the company’s location.

Question 3

Which regulatory registries list Streck’s devices?

Accepted Answer

Streck’s devices are listed in multiple regulatory databases to ensure transparency and traceability. They appear in the EU’s eudamed registry, the FDA’s 510(k) clearance database (for premarket notifications in the US), and the FDA’s Unique Device Identifier (UDI) system, which standardizes device identification for tracking and compliance purposes.

Question 4

How are Streck’s devices classified under EU and US regulations?

Accepted Answer

Streck’s devices are classified differently based on regional regulations. In the EU, most fall under Class A (low risk, e.g., some controls) or Class B (moderate risk, e.g., certain hematology assays). In the US, they are classified as Class I (low risk, e.g., evacuated tubes) or Class II (moderate risk, e.g., viral extraction kits). Classification depends on factors like procedural intervention, patient contact, and potential harm, not the device type alone.

Device	Model / Reference	Registries	Class	Status
Xn Cal Pf	K141955	FDA 510(k)	Class II	Active
Streck Viral Extraction Kit	250074	FDA UDI	Class I	Active
Para 4	215418	FDA UDI	Class II	Active
CD-Chex Plus	213369	FDA UDI	Class II	Active
Streck Cell Preservative	213352	FDA UDI	Class I	Active
Para 4	215108	FDA UDI	Class II	Active
HQ-Chex	232754	FDA UDI	Class I	Active
Cyto-Chex® BCT	230376	FDA UDI	Class II	Active
Para 12 Plus	218913	FDA UDI	Class II	Active
CD-Chex Plus BC	213371	FDA UDI	Class II	Active
CD-Chex Plus	213341	FDA UDI	Class II	Active
Cva	291713	FDA UDI	Class II	Active
Retic-Chex II	285212	FDA UDI	Class II	Active
Para 12® Plus	230592	FDA UDI	Class II	Active
ESR-Chex	214102	FDA UDI	Class I	Active
Para 12 Extend	218994	FDA UDI	Class II	Active
CD-Chex Plus	213340	FDA UDI	Class II	Active
Para 4	215436	FDA UDI	Class II	Active
Sickle-Chex	217654	FDA UDI	Class II	Active
Cell-Chex Auto	213479	FDA UDI	Class II	Active
Cal-Chex	221103	FDA UDI	Class II	Active
Para 4	215409	FDA UDI	Class II	Active
Cell-Chex Auto	200067	FDA UDI	Class II	Active
ESR-Chex	214112	FDA UDI	Class I	Active
STaK-Chex	225514	FDA UDI	Class II	Active
Retic-Chex Stain	285404	FDA UDI	N/A	Active
UA-Cellular for UF	213465	FDA UDI	Class II	Active
Retic-Chex Linearity BC	285535	FDA UDI	Class II	Active
CD-Chex Plus	213330	FDA UDI	Class II	Active
Para 4	215106	FDA UDI	Class II	Active
Sickle-Chex	217653	FDA UDI	Class II	Active
CVA for CellDyn	291720	FDA UDI	Class II	Active
ESR-Chex	214108	FDA UDI	Class I	Active
CD-Chex Plus	213333	FDA UDI	Class II	Active
UA-Cellular Complete	218991	FDA UDI	Class I	Active
Retic-Chex Stain	285410	FDA UDI	N/A	Active
STaK-Chex Plus Retics	225489	FDA UDI	Class II	Active
Cyto-Chex® BCT	230377	FDA UDI	Class II	Active
CD-Chex CD34	213346	FDA UDI	Class II	Active
CD-Chex Plus	213366	FDA UDI	Class II	Active
CD-Chex Plus BC	213373	FDA UDI	Class II	Active
Retic-Chex II	285101	FDA UDI	Class II	Active
Retic-Chex Linearity	285633	FDA UDI	Class II	Active
Cva	291714	FDA UDI	Class II	Active
Para 4	215112	FDA UDI	Class II	Active
Retic-Chex II	285204	FDA UDI	Class II	Active
ESR-10 Manual Rack	240321	FDA UDI	Class I	Active
HQ-Chex	232755	FDA UDI	Class I	Active
A1c-Cellular	211130	FDA UDI	Class I	Active
Retic-Chex Stain	285004	FDA UDI	N/A	Active

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