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Aimstrip Hemoglobin Starter Kit 200

FDA UDI

Class II (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
AIMSTRIP HEMOGLOBIN STARTER KIT 200 FDA UDI
Generic Name
Total haemoglobin (totHb) IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
For testing hemoglobin in whole blood FDA UDI
Model / Reference
78200 FDA UDI
Description
For testing hemoglobin in whole blood FDA UDI

Identifiers

Primary DI / UDI-DI
00695684782009 FDA UDI
FDA Product Code
KHG FDA UDI
GIG FDA UDI
GMDN Term
Total haemoglobin (totHb) IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7500 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

Yes

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

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 haemoglobin (totHb) IVD, kit, enzyme spectrophotometry

Aimstrip Hemoglobin Starter Kit 200 by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total haemoglobin (totHb) IVD, kit, enzyme spectrophotometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Germaine Laboratories, Inc.

Sources (1)

  • FDA UDI 8eefc48a-c057-4846-8dca-97e9e20c706e 33 fields · synced May 31, 2026