FDA UDI In Commercial Distribution 🇺🇸 United States

InTray® Mueller Hinton Chocolate Agar

DI: B08824830 · Model: 2483 · BIO-MED DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

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Basic Information

Brand Name
InTray® Mueller Hinton Chocolate Agar
Primary DI
B08824830
Version / Model
2483
Catalog Number
22-483-001
Company Name
BIO-MED DIAGNOSTICS, INC.
Labeler DUNS
605213545
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-10-16
Public Version
2
Public Version Date
2020-02-04
Public Version Status
Update
Public Device Record Key
d00ea085-7b13-4a76-b77a-90d43952336f

Device Description

Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.

Device Characteristics

Single Use
Yes
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JSG Culture Media, Non-Selective And Non-Differential

GMDN Terms

Code Name
58639 Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

Identifiers

Type ID
Package B08824834
Primary B08824830
Package B08824832