← Back to catalogue

Pointe Scientific, Inc.

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific, Inc. FDA UDI
Generic Name
Total/prostatic acid phosphatase (TcP) IVD, kit, spectrophotometry FDA UDI
Device Name
Acid Phosphatase Reagent Set for the quantitative determination of acid phosphatase in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 6 x 10ml FDA UDI
Model / Reference
HA703-60 FDA UDI
Description
Acid Phosphatase Reagent Set for the quantitative determination of acid phosphatase in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 6 x 10ml FDA UDI

Identifiers

Catalog Number
HA703-60 FDA UDI
Primary DI / UDI-DI
00811727012210 FDA UDI
510(k) Number
K863832 FDA UDI
FDA Product Code
JFH FDA UDI
GMDN Term
Total/prostatic acid phosphatase (TcP) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1020 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: Total/prostatic acid phosphatase (TcP) IVD, kit, spectrophotometry

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

Similar devices

Also classified as Total/prostatic acid phosphatase (TcP) IVD, kit, spectrophotometry.

Cleared under the same submission

K863832 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pointe Scientific, Inc.

Sources (1)

  • FDA UDI c3bceb59-a863-476d-82da-cf826566b317 37 fields · synced Jun 8, 2026