7-Amino Plus 100 Ng/Ml

FDA UDI

Class I (US FDA UDI)

by Utak Laboratories, Inc.

Identity

Trade Name: 7-AMINO PLUS 100 NG/ML FDA UDI
Generic Name: Benzodiazepine group IVD, control FDA UDI
Device Name: 7-AMINO PLUS 100 NG/ML FDA UDI
Model / Reference: 7-AMINO+ 100 MP FDA UDI
Description: 7-AMINO PLUS 100 NG/ML FDA UDI

Identifiers

Primary DI / UDI-DI: B80000357500030 FDA UDI
FDA Product Code: LAS FDA UDI
GMDN Term: Benzodiazepine group IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3280 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Benzodiazepine group IVD, control

7-Amino Plus 100 Ng/Ml by Utak Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Utak Laboratories, Inc.

Sources (1)

FDA UDI fc2b20f3-2e70-43ad-916c-5bf78aa0788a 34 fields · synced May 30, 2026