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Pointe Scientific, Inc.

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific, Inc. FDA UDI
Generic Name
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
IgE for the quantitative determination of Immunoglobulin E (IgE) concentration in human serum. For in vitro diagnostic use only. 96 Tests. FDA UDI
Model / Reference
P1035-96 FDA UDI
Description
IgE for the quantitative determination of Immunoglobulin E (IgE) concentration in human serum. For in vitro diagnostic use only. 96 Tests. FDA UDI

Identifiers

Catalog Number
P1035-96 FDA UDI
Primary DI / UDI-DI
00811727013330 FDA UDI
510(k) Number
K992528 FDA UDI
FDA Product Code
DGC FDA UDI
GMDN Term
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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: Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K992528 also covers:

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 6eb44cf9-128f-420e-b66a-e3cdcbb60e03 37 fields · synced May 30, 2026