POINTE SCIENTIFIC, INC.

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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

Bromcresol Green Dye-Binding, Albumin (CIX) (4) Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (DIC) (2) Acid Phosphatase (Prostatic), Tartrate Inhibited (JFH) (1) Calibrators, Ethyl Alcohol (DNN) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1)

Premarket Exempt

No Yes

Clear

Pointe Scientific, Inc. - 00811727010001 Catalog Number : A7503-100

Device Description : Acid Phosphatase Reagent Set used for the quantitative determination of acid pho Acid Phosphatase Reagent Set used for the quantitative determination of acid phosphatase in serum.10x10ml Reagent.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : JFH

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Albumin - 00811727010018 Catalog Number : A7502-120

Device Description : For the quantitative determination of Albumin in serum.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC ALBUMIN - 00811727010025 Catalog Number : A7502-500

Device Description : For the quantitative determination of Albumin in serum.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC ALBUMIN - 00811727010032 Catalog Number : A7502-1L

Device Description : For the quantitative determination of Albumin in serum.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Albumin Standard - 00811727010049 Catalog Number : A7502-STD

Device Description : Intended for use as an albumin standard for standardization or calibration of br Intended for use as an albumin standard for standardization or calibration of bromocresol green (BCG) dye-binding albumin procedures.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC ALCOHOL - 00811727010056 Catalog Number : A7504-39

Device Description : For the quantitative determination of ethyl alcohol in serum or whole blood. Fo For the quantitative determination of ethyl alcohol in serum or whole blood. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : DIC

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC ALCOHOL - 00811727010063 Catalog Number : A7504-150

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : DIC

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Ammonia/Alcohol Controls - 00811727010070 Catalog Number : A7504-CTL

Device Description : "For in vitro diagnostic use only.The Pointe Scientific, Inc. Ammonia / Alcohol "For in vitro diagnostic use only.The Pointe Scientific, Inc. Ammonia / Alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. (475 characters)"

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Alcohol Standard - 00811727010087 Catalog Number : A7504-STD

Device Description : The Alcohol standard is intended as a means of calibrating various ethanol assay methods.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : DNN

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) - 00811727010131 Catalog Number : A7516-150

Device Description : For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

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