Identity
- Trade Name
- Dimension® Flex® reagent cartridge GGT FDA UDI
- Generic Name
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Y-Glutamyl Transferase Flex® reagent cartridge, 288 (4x72) tests FDA UDI
- Model / Reference
- 10444960 FDA UDI
- Description
- Y-Glutamyl Transferase Flex® reagent cartridge, 288 (4x72) tests FDA UDI
Identifiers
- Catalog Number
- DF45A FDA UDI
- Primary DI / UDI-DI
- 00842768014154 FDA UDI
- 510(k) Number
- K861700 FDA UDI
- FDA Product Code
- JQB FDA UDI
- GMDN Term
- Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1360 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: Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Dimension® Flex® reagent cartridge GGT by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry.
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- CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209 — Carolina Liquid Chemistries Corp. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- GAMMA-GT SZASZ SL — VITALSCIENTIFIC
- gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz — Roche Diagnostics Corp. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
Cleared under the same submission
K861700 also covers:
- Dimension® CHEM II Calibrator — Siemens Healthcare Diagnostics
- Dimension® CHOL Calibrator — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge ALB — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge CHOL — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge MG — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI d117887a-44e7-425c-853e-e70b0dd7f2df 37 fields · synced Jun 8, 2026