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
Retic-Chex II	285211	FDA UDI	Class II	Active
Para 12 Extend	218753	FDA UDI	Class II	Active
Sickledex	217660	FDA UDI	Class II	Active
Retic-Chex II	285304	FDA UDI	Class II	Active
Streck Cell Preservative	213350	EUDAMEDFDA UDI	Class A	Active
Nrbc-Chex For Lh	K060083	FDA 510(k)	Class II	Active
MDx-Chex for BCP	K260041	FDA 510(k)	Class II	Active
Ua-Cellular For Iq	K090201	FDA 510(k)	Class II	Active
Cell-Chex	K101335	FDA 510(k)	Class II	Active
X-Cal	K083200	FDA 510(k)	Class II	Active
Cyto-Chex Bct	K080552	FDA 510(k)	Class II	Active
Retic-Chex Linearity For Bc	K070199	FDA 510(k)	Class II	Active
UA-Cellular Complete	K170091	FDA 510(k)	Class I	Active
Cell-Dyn 22 Plus Calibrator	K111204	FDA 510(k)	Class II	Active
MDx-Chex for BCID2	K212576	FDA 510(k)	Class II	Active
Cell-Chex With Cppd Crystals	K110718	FDA 510(k)	Class II	Active
Cell-Chex Auto	K053362	FDA 510(k)FDA UDI	Class II	Active
MDx-Chex for BCN	K254166	FDA 510(k)	Class II	Active
Cd4 Count	K083926	FDA 510(k)	Class II	Active
Nrbc-Chex For Advia	K080016	FDA 510(k)	Class II	Active
MDx-Chex for BC-GN	K231223	FDA 510(k)	Class II	Active
Iq Body Fluids Control	K051706	FDA 510(k)	Class II	Active
Cell-Dyn 22 Plus Control	K111211	FDA 510(k)	Class II	Active
E-Check (xe)	K063218	FDA 510(k)	Class II	Active
Ua-Cellular Complete	K131444	FDA 510(k)	Class I	Active
MDx-Chex for BC-GP	K231221	FDA 510(k)	Class II	Active
Cd-Chex Plus Bc	K051633	FDA 510(k)	Class II	Active
Stak-Chex Plus Retics	K090137	FDA 510(k)FDA UDI	Class II	Active
MDx-Chex for BCY	K254167	FDA 510(k)	Class II	Active
Streck	212425	EUDAMEDFDA UDI	Class B	Active
Streck	225482	EUDAMEDFDA UDI	Class B	Active
Streck	213362	EUDAMEDFDA UDI	Class A	Active
Streck	213361	EUDAMEDFDA UDI	Class A	Active
Cell-Free DNA BCT	230469	EUDAMEDFDA UDI	Class A	Active
Streck	213386	EUDAMEDFDA UDI	Class A	Active
Para 12 Plus	218934	EUDAMEDFDA UDI	Class B	Active
Streck	212431	EUDAMEDFDA UDI	Class B	Active
Streck	212432	EUDAMEDFDA UDI	Class B	Active
Streck	230202	EUDAMEDFDA UDI	Class B	Active
Cell-Free DNA BCT	230471	EUDAMEDFDA UDI	Class A	Active
Streck Cell-Free DNA BCT CE	218996	EUDAMED	Class A	Active
Streck	218750	EUDAMEDFDA UDI	Class B	Active
Streck	225483	EUDAMEDFDA UDI	Class B	Active
Streck	218776	EUDAMEDFDA UDI	Class B	Active
Streck	212429	EUDAMEDFDA UDI	Class B	Active
Streck	218758	EUDAMEDFDA UDI	Class B	Active
Streck	212430	EUDAMEDFDA UDI	Class B	Active
Para 12 Plus	218924	EUDAMEDFDA UDI	Class B	Active
Cell-Free DNA BCT	230470	EUDAMEDFDA UDI	Class A	Active
Streck	218995	EUDAMEDFDA UDI	Class B	Active

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