FDA.reportPublic FDA data

AnaeroGRO

Primary DI
00816576024506
Brand
AnaeroGRO
Company
HARDY DIAGNOSTICS
Model
AG401
Catalog number
AG401
Device description
Egg Yolk Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics AnaeroGRO™ Egg Yolk Agar, Modified is an enriched, non-selective, and differential medium recommended for use in the detection of lecithinase and lipase production and proteolytic activity of certain obligate anaerobes and in the presumptive identification of various Clostridium, Fusobacterium, and Prevotella spp.; it is also used in the Nagler Test for the presumptive identification of Clostridium perfringens.
Published
2020-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSHCulture Media, Non-Selective And Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576024506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576024506008165760245068165760245060816576024506

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819398026086N/AY62Y622020-06-09
00816576027194HardyDisk™Z9495Z94952025-08-08
00816576027200HardyDisk™Z9491Z94912025-08-08
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818207025088Endocator Swabs (20pk)Vista DentalJSH2025-11-07
B6450715EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0713EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0714EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0718EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0722EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0771EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0772EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0775EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B64507151EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07131EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07181EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07221EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07721EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07751EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B6453B014EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P355EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P444EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645T0096EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6453B0141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P3551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P4441EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645B0318EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645T00961EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6452P185EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B6453P080EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17