Identity
- Trade Name
- m2000 FDA UDI
- Generic Name
- Test tube rack FDA UDI
- Device Name
- m2000 System Pierceable Cap Sample Rack Set FDA UDI
- Model / Reference
- 01N97-01 FDA UDI
- Description
- m2000 System Pierceable Cap Sample Rack Set FDA UDI
Identifiers
- Catalog Number
- 01N97-01 FDA UDI
- Primary DI / UDI-DI
- 00884999001381 FDA UDI
- 510(k) Number
- K092705 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Test tube rack FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Test tube rack
m2000 by Abbott Molecular — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Test tube rack.
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- Medco Manufacturing — Medco Manufacturing LLC · Class I
- LabChoice Tube Racks, 90 Holes, Fits 13 mm Tubes — Dynarex Corp. · Class I
- OSMETTE Sample Tube Rack, 50 ul — PRECISION SYSTEMS, INC. · Class I
- Medco Manufacturing — Medco Manufacturing LLC · Class I
- Medco Manufacturing — Medco Manufacturing LLC · Class I
- MEDLINEUNITE — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K092705 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI c1f7b5ce-ede5-40e5-a168-b6b70b03101a 36 fields · synced May 30, 2026