CAMBRIDGE DIAGNOSTIC PRODUCTS INC

Address:6880 NW 17TH AVE,Fort Lauderdale,FL,33309,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

Stains, Hematology (KQC) (4) General Purpose Reagent (PPM) (3) Fixative, Alcohol Containing (LDZ) (1) Guaiac Reagent (GGG) (1) Reagent, Occult Blood (KHE) (1)

Premarket Exempt

No Yes

Clear

Camco - 00691573100305 Catalog Number : 1003

Device Description : Guaiac Tablets for qualitative determination of fecal occult blood

Device Class : 2

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : GGG

Prescription Use : No

Device Count : 1

Camco - 00691573200005 Catalog Number : 2000

Device Description : Camco Poly-Tet stain - Wright stain with blue-red coloration with high intensity Camco Poly-Tet stain - Wright stain with blue-red coloration with high intensity color projection and electrolytes for sharper contrast.

Device Class : 1

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : KQC

Prescription Use : No

Device Count : 1

Camco - 00691573205000 Catalog Number : 205

Device Description : Camco liquid anticoagulant for blood preservation - EDTA solution

Device Class : 1

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Camco - 00691573210035 Catalog Number : 210

Device Description : Camco Quik Stain Buffered differential stains used in the staining of blood smea Camco Quik Stain Buffered differential stains used in the staining of blood smears for hematological study.

Device Class : 1

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : KQC

Prescription Use : No

Device Count : 1

Camco - 00691573211032 Catalog Number : 211

Device Description : Camco Quik Stain II - Wright-Giemsa stain - traditional blue-red coloration with Camco Quik Stain II - Wright-Giemsa stain - traditional blue-red coloration with additional red highlights.

Device Class : 1

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : KQC

Prescription Use : No

Device Count : 1

Camco - 00691573400009 Catalog Number : 400

Device Description : Camco Wright Stain solution for automated and manual staining of blood smears fo Camco Wright Stain solution for automated and manual staining of blood smears for hematological studies.

Device Class : 1

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : KQC

Prescription Use : No

Device Count : 1

Camco - 00691573401006 Catalog Number : 401

Device Description : Camco Wright Stain Fixative for automated and manual staining.

Device Class : 1

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : LDZ

Prescription Use : No

Device Count : 1

Camco - 00691573402003 Catalog Number : 402

Device Description : Camco Wright Stain Buffer pH 7.15 to reconstitute and use in hematology staining.

Device Class : 1

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Camco - 00691573412002 Catalog Number : 412

Device Description : Camco Wright Stain Buffer pH 6.8 reconstitute and use in hematology staining.

Device Class : 1

Duns Number: 069146876

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Camco - 00691573700154 Catalog Number : 700-C-1

Device Description : Positive control for guaiac based fecal occult blood slide tests

Device Class : 2

Duns Number: 069146876

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

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