Identity
- Trade Name
- Xpert GBS LB FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Xpert GBS LB kit; 120 test kit FDA UDI
- Model / Reference
- GXGBS-LB-120 FDA UDI
- Description
- Xpert GBS LB kit; 120 test kit FDA UDI
Identifiers
- Catalog Number
- GXGBS-LB-120 FDA UDI
- Primary DI / UDI-DI
- 07332940000806 FDA UDI
- 510(k) Number
- K121539 FDA UDI
- FDA Product Code
- NJR FDA UDI
- GMDN Term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 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
Yes
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: Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert GBS LB by Cepheid — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Alethia™ Group B Streptococcus — MERIDIAN BIOSCIENCE, INC. · Class I
- Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Group B Strep Assay — Great Basin Scientific, Inc. · Class II
- Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Simplexa™ GBS Direct — DiaSorin Molecular LLC · Class II
- Revogene GBS LB — MERIDIAN BIOSCIENCE, INC. · Class I
Cleared under the same submission
K121539 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
- Cepheid
Sources (1)
- FDA UDI f195c0fe-b654-4176-b4ca-a401ab5d32a5 37 fields · synced May 30, 2026