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
ESR-Auto Plus	506	FDA UDI	Class I	Active
Para 4	215412	FDA UDI	Class II	Active
CD-Chex Plus	213327	FDA UDI	Class II	Active
CD-Chex CD34	213339	FDA UDI	Class II	Active
ESR-Chex	214104	FDA UDI	Class I	Active
CD-Chex Plus	213370	FDA UDI	Class II	Active
Para 12 Extend	218751	FDA UDI	Class II	Active
Para 4	215103	FDA UDI	Class II	Active
Para 4	215115	FDA UDI	Class II	Active
Cal-Chex	221101	FDA UDI	Class II	Active
ESR-Vacuum tubes	240377	FDA UDI	Class I	Active
MDx-Chex for BCID2	250065	FDA UDI	Class II	Active
ESR-Chex Plus	240411	FDA UDI	Class I	Active
HQ-Chex	232753	FDA UDI	Class I	Active
Cal-Chex A Plus	221106	FDA UDI	Class II	Active
Para 12 Plus	218907	FDA UDI	Class II	Active
Cell-Chex Auto	200065	FDA UDI	Class II	Active
Cal-Chex A Plus	221108	FDA UDI	Class II	Active
CD-Chex CD34	213382	FDA UDI	Class II	Active
STaK-Chex	225512	FDA UDI	Class II	Active
CD-Chex Plus BC	213377	FDA UDI	Class II	Active
Cal-Chex A Plus	221107	FDA UDI	Class II	Active
HQ-Chex	232757	FDA UDI	Class I	Active
CD-Chex Plus BC	213372	FDA UDI	Class II	Active
UA-Cellular for IQ	213396	FDA UDI	Class II	Active
CD-Chex Plus BC	213375	FDA UDI	Class II	Unknown
CD-Chex Plus	213365	FDA UDI	Class II	Active
Cell-Chex Auto	200069	FDA UDI	Class II	Active
CD-Chex Plus	213367	FDA UDI	Class II	Active
CD-Chex Plus	213331	FDA UDI	Class II	Active
CD-Chex Plus	213325	FDA UDI	Class II	Active
Cva	291504	FDA UDI	Class II	Active
Cyto-Chex BCT	213559	FDA UDI	Class II	Active
Retic-Chex II	285104	FDA UDI	Class II	Active
STaK-Chex	225524	FDA UDI	Class II	Active
Cva	291708	FDA UDI	Class II	Active
CD-Chex Plus BC	213374	FDA UDI	Class II	Active
Sperm-Chex Post VC	230200	FDA UDI	Class II	Active
STaK-Chex	225503	FDA UDI	Class II	Active
Sickledex	217661	FDA UDI	Class II	Active
CD-Chex CD34	213383	FDA UDI	Class II	Active
ESR-Vacuum tubes	240213	FDA UDI	Class I	Active
HQ-Chex	232758	FDA UDI	Class I	Active
HQ-Chex	232756	FDA UDI	Class I	Active
A1c-Cellular Linearity	285536	FDA UDI	Class I	Active
ESR-Chex	214014	FDA UDI	Class I	Active
Retic-Chex Stain	285005	FDA UDI	N/A	Active
ESR-Vacuum tubes	240364	FDA UDI	Class I	Active
CVA for CellDyn	291715	FDA UDI	Class II	Active
ESR-Chex Plus	240408	FDA UDI	Class I	Active

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