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Pointe Scientific, Inc.

FDA UDI

Class I (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific, Inc. FDA UDI
Generic Name
Inorganic phosphate (PO43-) IVD, calibrator FDA UDI
Device Name
Phosphorus Standard, intended for use as an phosphorus standard for standardization or calibration of phosphomolybdate phosphorus procedures. Size: 1 x 15 mL. Concentration: 5 mg/dL FDA UDI
Model / Reference
13-P7516-STD FDA UDI
Description
Phosphorus Standard, intended for use as an phosphorus standard for standardization or calibration of phosphomolybdate phosphorus procedures. Size: 1 x 15 mL. Concentration: 5 mg/dL FDA UDI

Identifiers

Catalog Number
13-P7516-STD FDA UDI
Primary DI / UDI-DI
00811727014375 FDA UDI
FDA Product Code
CEO FDA UDI
GMDN Term
Inorganic phosphate (PO43-) IVD, calibrator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Inorganic phosphate (PO43-) IVD, calibrator

Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inorganic phosphate (PO43-) IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pointe Scientific, Inc.

Sources (1)

  • FDA UDI 4c718f5f-65c1-4447-9ef4-9cc46ad26620 36 fields · synced May 31, 2026