MEDICAL CHEMICAL CORPORATION

Address:19430 VAN NESS AVE,TORRANCE,CA,90501,US

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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

Container, Specimen, Non-Sterile (NNI) (6) Culture Media, Non-Propagating Transport (JSM) (6) Fixative, Metallic Containing (LDX) (5) Formalin, Neutral Buffered (IFP) (3) Cryptosporidium Spp. (MHJ) (1) Giardia Spp. (MHI) (1)

Premarket Exempt

Clear

Unifix / Clean / C&S Kits O&P Collection Vials - M445891101 Catalog Number : 891-10

Device Description : Convenience kit containing Unifix, Clean and C&S Vials.

Device Class : 1

Duns Number: 008496861

Premarket Exempt : No

Product Code : JSM, LDX, NNI

Prescription Use : Yes

Device Count : 36

Total-Fix / C&S / Clean O&P Collection Kits - M445891171 Catalog Number : 891-17

Device Description : Convenience kit containing Total Fix, C&S and Clean Vials.

Device Class : 1

Duns Number: 008496861

Premarket Exempt : No

Product Code : JSM, LDX, NNI

Prescription Use : Yes

Device Count : 36

Total-Fix / C&S / Clean O&P Collection Kits - M44589117ORNGE1 Catalog Number : 891-17_ORNGE

Device Description : Convenience kit containing Total Fix, C&S and Clean Vials with orange caps.

Device Class : 1

Duns Number: 008496861

Premarket Exempt : No

Product Code : JSM, LDX, NNI

Prescription Use : Yes

Device Count : 36

Formalin / C&S / Clean Stool Collection Kits - M445891201 Catalog Number : 891-20

Device Description : Convenience kit containing Formalin, C&S and Clean Vials for stool collection.

Device Class : 1

Duns Number: 008496861

Premarket Exempt : No

Product Code : IFP, JSM, NNI

Prescription Use : Yes

Device Count : 36

Total-Fix / Formalin / C&S / Clean O&P Collection Kits - M445892021 Catalog Number : 892-02

Device Description : Convenience kit containing Total Fix, Formalin, C&S and Clean Vials for stool sa Convenience kit containing Total Fix, Formalin, C&S and Clean Vials for stool sample collection.

Device Class : 1

Duns Number: 008496861

Premarket Exempt : No

Product Code : JSM, LDX, NNI, IFP

Prescription Use : Yes

Device Count : 24

Z-PVA / Formalin / C&S / Clean O&P Collection Kits - M445892031 Catalog Number : 892-03

Device Description : Convenience kit containing Zinc PVA, Formalin, C&S and Clean Vials for stool sam Convenience kit containing Zinc PVA, Formalin, C&S and Clean Vials for stool sample collection.

Device Class : 1

Duns Number: 008496861

Premarket Exempt : No

Product Code : JSM, LDX, NNI, IFP

Prescription Use : Yes

Device Count : 24

Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay - M445MCCCGDFA750 Catalog Number : MCC-C/G-DFA 75

Device Description : The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts and Giardia cysts in human stool by direct immunofluorescence microscopy. This kit contains enough reagents for 75 tests.

Device Class : 2

Duns Number: 008496861

Premarket Exempt : No

Product Code : MHI, MHJ

Prescription Use : Yes

Device Count : 1

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