Identity
- Trade Name
- BioCode SA-PE Mix Pack FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Fluorescence dye for MDx 3000 assays. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Fluorescence dye for MDx 3000 assays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851034007042 FDA UDI
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biological stain IVD
BioCode SA-PE Mix Pack by Applied BioCode, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Applied BioCode, Inc.
Sources (1)
- FDA UDI 46d5c808-17b6-48e8-9e84-0e8705e320e6 34 fields · synced Jun 6, 2026