Identity
- Trade Name
- BioCode MDx 3000 Buffer A FDA UDI
- Generic Name
- Immunohistochemistry wash buffer reagent IVD FDA UDI
- Device Name
- Buffer used in MDx 3000 assays. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Buffer used in MDx 3000 assays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851034007035 FDA UDI
- GMDN Term
- Immunohistochemistry wash buffer reagent 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: Immunohistochemistry wash buffer reagent IVD
BioCode MDx 3000 Buffer A by Applied BioCode, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Immunohistochemistry wash buffer reagent IVD.
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- Immunocare TBS Wash Buffer 10X — BIOCARE MEDICAL, LLC · Class I
- 20% Tween 20 — BIOCARE MEDICAL, LLC · Class I
- IHC — Slmp, LLC · Class I
- IMMUNO CONCEPTS RELISA® Test Systems — IMMUNO CONCEPTS INC
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 347df91e-890e-4258-8f44-82633bf8129b 34 fields · synced Jun 6, 2026