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Bartels

FDA UDI

Class I (US FDA UDI)

by Clark Laboratories, Inc.

Identity

Trade Name
Bartels FDA UDI
Generic Name
Viral transport medium IVD FDA UDI
Device Name
ChlamTrans, Chlamydial Transport Medium FDA UDI
Model / Reference
B1029-56D FDA UDI
Description
ChlamTrans, Chlamydial Transport Medium FDA UDI

Identifiers

Catalog Number
B1029-56D FDA UDI
Primary DI / UDI-DI
05391516747349 FDA UDI
510(k) Number
K834125 FDA UDI
FDA Product Code
JSM FDA UDI
GMDN Term
Viral transport medium IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2390 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

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

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: Viral transport medium IVD

Bartels by Clark Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Viral transport medium IVD.

Cleared under the same submission

K834125 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clark Laboratories, Inc.

Sources (1)

  • FDA UDI 1a01a30f-2146-444c-bde6-bd2233600399 38 fields · synced Jun 8, 2026