Identity
- Trade Name
- Antiserum to Human Myoglobin FDA UDI
- Generic Name
- Myoglobin IVD, antibody FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 131002 FDA UDI
- Primary DI / UDI-DI
- B176131 FDA UDI
- 510(k) Number
- K771242 FDA UDI
- FDA Product Code
- DDR FDA UDI
- GMDN Term
- Myoglobin IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5680 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: Myoglobin IVD, antibody
Antiserum to Human Myoglobin by Kent Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myoglobin IVD, antibody.
- Myoglobin Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Myoglobin Antibody, EP87 — EPITOMICS, INC. · Class I
- Tinto Myoglobin, RPab — BIO SB, INC. · Class I
- Myoglobin Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Tinto Myoglobin, RPab — BIO SB, INC. · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Myoglobin RPab — BIO SB, INC. · Class I
- Rabbit Monoclonal Anti-Human Myoglobin Antibody, EP87 — EPITOMICS, INC. · Class I
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
- Kent Laboratories, Inc.
Sources (1)
- FDA UDI 85094cb7-0fe6-4fce-a7c9-aaf0d506150a 34 fields · synced May 31, 2026