FDA UDI In Commercial Distribution 🇺🇸 United States

Tinto IgG MMab

DI: B502BSB56740 · Model: Predilute, 7 ml · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Tinto IgG MMab
Primary DI
B502BSB56740
Version / Model
Predilute, 7 ml
Catalog Number
BSB 5674
Company Name
BIO SB, INC.
Labeler DUNS
102855447
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-31
Public Version
1
Public Version Date
2020-09-08
Public Version Status
New
Public Device Record Key
3d82d77c-f55c-450c-a3bc-13d6fd4cff16

Device Description

IgG antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in Phosphate Buffered Saline, pH 7.6, with protein base, and preserved with Sodium Azide preservative.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NJT Immunohistochemistry Reagents And Kits

GMDN Terms

Code Name
57316 Total immunoglobulin G (IgG total) IVD, antibody

Identifiers

Type ID
Primary B502BSB56740