Identity
- Trade Name
- Fisherbrand FDA UDI
- Generic Name
- Glucose IVD, reagent FDA UDI
- Device Name
- Glucose Tolerance Beverage 50G PNCH NC PLAS FDA UDI
- Model / Reference
- 401576FB FDA UDI
- Description
- Glucose Tolerance Beverage 50G PNCH NC PLAS FDA UDI
Identifiers
- Catalog Number
- 401576FB FDA UDI
- Primary DI / UDI-DI
- 00613647000823 FDA UDI
- 510(k) Number
- K032753 FDA UDI
- FDA Product Code
- MRV FDA UDI
- GMDN Term
- Glucose IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
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
Yes
FDA UDI
Category: Glucose IVD, reagent
Fisherbrand by Fisher Scientific Company L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose IVD, reagent.
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Cleared under the same submission
K032753 also covers:
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Thermo Scientific GlucoCrush™ — Fisher Diagnostics
- Thermo Scientific GlucoCrush™ — Fisher Diagnostics
- Thermo Scientific GlucoCrush™ — Fisher Diagnostics
- Thermo Scientific GlucoCrush™ — Fisher 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 II | Pending data |
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Manufacturer
- Manufacturer
- Fisher Scientific Company L.l.c.
Sources (1)
- FDA UDI 822b7876-7136-49d9-ad28-0019ebbc954a 36 fields · synced May 31, 2026