FDA.report

Monobind AccuLite TSH CLIA Kit - 480 Wells

Primary DI
00816870023243
Brand
Monobind AccuLite TSH CLIA Kit - 480 Wells
Company
MONOBIND, INC.
Model
375-300
Catalog number
375-300D
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JLWRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Product Code Classifications

CodeDeviceSpecialtyClass
JLWRadioimmunoassay, Thyroid-Stimulating HormoneClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816870023243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870023243008168700232438168700232430816870023243

GMDN Terms

TermDefinition
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using a chemiluminescent immunoassay method.

Device Sizes

TypeValueUnit
Width12Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Handling Environment Temperature
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(949)951-2665info@monobind.com

Regulatory Flags

DUNS number
083155515
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00816870021300903 DBS Collection Cards - 5 Samples621MM621MM2024-09-13
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00816870023366Vit D Direct AccuLite CLIA Test System - 96 wells9475-3009475-300A2024-09-13
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