STRECK, INC.

Address:11710 Peel Circle,La Vista,NE,68128,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mixture, Hematology Quality Control (JPK) (5) Control, White-Cell (GGL) (4) Mixture, Control, White-Cell And Red-Cell Indices (GLQ) (1)

Premarket Exempt

No Yes

Clear

Retic-Chex II - 00844509000440 Catalog Number : 285211

Device Description : A tri-level control manufactured with reticulocytes that resemble the appearance

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Retic-Chex II - 00844509000457 Catalog Number : 285212

Device Description : A tri-level control manufactured with reticulocytes that resemble the appearance

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

CD-Chex CD34 - 00844509000495 Catalog Number : 213338

Device Description : A positive procedural control for enumerating CD34 positive cells by flow cytome

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : GGL

Prescription Use : No

Device Count : 1

CD-Chex CD34 - 00844509000501 Catalog Number : 213339

Device Description : A positive procedural control for enumerating CD34 positive cells by flow cytome

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : GGL

Prescription Use : No

Device Count : 1

CD-Chex Plus BC - 00844509000532 Catalog Number : 213375

Device Description : A positive procedural control for monitoring immunophenotyping by flow cytometry

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : GGL

Prescription Use : No

Device Count : 1

CD-Chex Plus BC - 00844509000549 Catalog Number : 213376

Device Description : A positive procedural control for monitoring immunophenotyping by flow cytometry

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : GGL

Prescription Use : No

Device Count : 1

Cell-Chex Auto - 00844509000587 Catalog Number : 200065

Device Description : Spinal and body fluid control for evaluating the accuracy and precision of hemat

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Cell-Chex Auto - 00844509000594 Catalog Number : 200066

Device Description : Spinal and body fluid control for evaluating the accuracy and precision of hemat

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Cell-Chex Auto - 00844509000600 Catalog Number : 213479

Device Description : Spinal and body fluid control for evaluating the accuracy and precision of hemat

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Para 12 Extend - 00844509000648 Catalog Number : 218750

Device Description : A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part D

Device Class : 2

Duns Number: 072915986

Premarket Exempt : No

Product Code : GLQ

Prescription Use : No

Device Count : 1

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