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Thrombo-TIC 1:100 pur

FDA UDI

Class I (US FDA UDI)

by BIOANALYTIC GmbH, biomed. Analysentechnik

Identity

Trade Name
Thrombo-TIC 1:100 pur FDA UDI
Generic Name
Platelet count IVD, reagent FDA UDI
Model / Reference
004015-6011DMD FDA UDI

Identifiers

Primary DI / UDI-DI
04061609000699 FDA UDI
FDA Product Code
JCG FDA UDI
GMDN Term
Platelet count IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.8200 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Platelet count IVD, reagent

Thrombo-TIC 1:100 pur by BIOANALYTIC GmbH, biomed. Analysentechnik — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Platelet count IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BIOANALYTIC GmbH, biomed. Analysentechnik

Sources (1)

  • FDA UDI ab2e2729-95d7-4569-b9a7-efe80b9111ba 32 fields · synced Jun 6, 2026