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Ins Elisa

FDA UDI

Class I (US FDA UDI)

by Diasource Immunoassays, S.A.

Identity

Trade Name
INS ELISA FDA UDI
Generic Name
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
INS ELISA FDA UDI
Model / Reference
KAP1251 FDA UDI
Description
INS ELISA FDA UDI

Identifiers

Primary DI / UDI-DI
05400569000117 FDA UDI
FDA Product Code
CFP FDA UDI
GMDN Term
Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1405 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, enzyme immunoassay (EIA)

Ins Elisa by Diasource Immunoassays, S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diasource Immunoassays, S.A.

Sources (1)

  • FDA UDI d35947cb-66e6-4ce6-b906-d1f2bac9798e 33 fields · synced Jun 8, 2026